Child Safety Packaging Regulations

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Questions and Answers

Which of the following products must be packaged according to the provisions of § 1700.15 if it contains more than 0.5 mg of its active component in a single retail package?

Minoxidil preparations with 14 mg or more

Ketoprofen preparations with 40 mg or less

Naproxen preparations with 200 mg or more

Dibucaine preparations with more than 0.5 mg (correct)

What is the minimum amount of naproxen in a single retail package that triggers packaging requirements under § 1700.15?

150 mg

300 mg

250 mg (correct)

200 mg

For which component does the requirement of more than 50 mg in a single retail package apply for packaging compliance under § 1700.15?

Ketoprofen (correct)

Naproxen

Dibucaine

Minoxidil

Which of the following statements is correct regarding fluoride packaging requirements?

0.5% elemental fluoride is the packaging threshold for liquids. Signup and view all the answers

What is the packaging requirement for minoxidil preparations containing more than 14 mg in a single retail package?

They must be packaged according to § 1700.15 (a), (b), and (c). Signup and view all the answers

Which provision sections must products containing more than 50 mg of elemental fluoride follow?

§ 1700.15 (a), (b), and (c) Signup and view all the answers

What is the maximum percentage of aspirin that can be present in effervescent tablets to be exempt from special packaging requirements?

15 percent Signup and view all the answers

Which of the following substances requires special packaging to prevent hazards to children?

Liquid methyl salicylate with more than 5 percent by weight Signup and view all the answers

What viscosity must nonemulsion type liquid furniture polishes have to require special packaging?

Less than 100 Saybolt universal seconds Signup and view all the answers

For which of the following is special packaging NOT required according to the provisions outlined?

Pressurized spray containers of furniture polish Signup and view all the answers

What is the specific condition for an aspirin-containing powder to not require special packaging?

It must contain no other substances Signup and view all the answers

What type of substances are controlled drugs categorized under in relation to special packaging requirements?

Substances requiring special packaging Signup and view all the answers

What condition must be met regarding the LD-50 value for aspirin-containing effervescent tablets to be exempt from special packaging?

LD-50 must be 5 grams or more per kilogram Signup and view all the answers

Which of the following packaging provisions applies to liquid preparations of methyl salicylate?

Must comply with provisions of § 1700.15 (a), (b), and (c) Signup and view all the answers

What is the minimum percentage by weight of sulfuric acid that requires packaging in compliance with § 1700.15 (a) and (b)?

10 percent Signup and view all the answers

Which of the following substances must be packaged according to § 1700.15 (a) and (b) if it contains 10 percent or more by weight?

Turpentine Signup and view all the answers

Which items are explicitly exempt from the packaging regulations under § 1700.15 (a), (b), and (c)?

Erythromycin ethylsuccinate granules for oral suspension Signup and view all the answers

What is the maximum concentration of elemental fluoride allowed for sodium fluoride preparations under the regulations?

0.5 percent Signup and view all the answers

Any household substance containing 2 percent or more by weight of chemically unneutralized sodium hydroxide must adhere to what packaging rule?

Must follow § 1700.15 (a) and (b) Signup and view all the answers

Which type of drug is required to be dispensed only by prescription under the mentioned regulations?

Oral contraceptives in mnemonic packages Signup and view all the answers

What must prepackaged liquid kindling preparations contain to fall under packaging regulations?

10 percent or more by weight of petroleum distillates Signup and view all the answers

Which substance is NOT listed among the household substances needed special packaging according to § 1700.15 (a) and (b)?

Acetic acid Signup and view all the answers

Which one of the following is a specific requirement for liquid household substances containing methyl alcohol?

Must contain 4 percent or more by weight Signup and view all the answers

Which type of household product containing a specific chemical must adhere to packaging regulations if it contains more than 500 mg of acetonitrile?

Glueremovers Signup and view all the answers

What is the threshold quantity of acetaminophen in a single package that triggers the need for specific packaging regulations?

More than 1 gram Signup and view all the answers

Which product's packaging must comply with regulations if it contains more than 66 mg of diphenhydramine in one package?

Antihistamines Signup and view all the answers

Which criteria exempt mouthwash products from strict packaging regulations regarding ethanol content?

Contains at least 7% mint or cinnamon flavoring oils and less than 15 grams of ethanol Signup and view all the answers

What is the dosage limit of loperamide in a single package that necessitates adherence to packaging provisions?

0.045 mg Signup and view all the answers

Which of the following requires packaging regulation if it contains more than 600 mg of sodium bromate?

Home permanent wave neutralizers Signup and view all the answers

What is the maximum amount of ibuprofen in a single package that triggers the need for compliant packaging?

1,000 mg Signup and view all the answers

Which of the following is true for acetaminophen in effervescent tablets or granules?

They are exempt if they contain less than 15% acetaminophen. Signup and view all the answers

What is the limiting amount of potassium bromate in home permanent wave neutralizers that necessitates compliance with packaging provisions?

50 mg Signup and view all the answers

In the context of mouthwash products, what qualifies as an absolute ethanol content requiring compliance?

3 g or more Signup and view all the answers

What is the maximum amount of methylprednisolone allowed per package without other substances?

84 mg Signup and view all the answers

Which of the following drugs is explicitly mentioned to have limits for both tablet and powder forms?

Colesevelam hydrochloride Signup and view all the answers

For which of the following substances is the stated limit in percentage for dietary supplements based on a weight-to-weight basis?

Iron-containing drugs Signup and view all the answers

What is the specific concentration limit set for iron in nonliquid preparations?

0.05 percent Signup and view all the answers

Which of these substances must be packaged according to § 1700.15 due to its ethylene glycol content?

Household substances Signup and view all the answers

What is the maximum allowable quantity of erythromycin in tablet form as per the standards?

16 grams Signup and view all the answers

What type of substances are exempted from the provisions for iron-containing drugs?

Animal feeds Signup and view all the answers

Which drug is placed under specific packaging requirements alongside hormone replacement therapy products?

Norethindrone Acetate Signup and view all the answers

What is the maximum quantity of baloxavir marboxil allowed per package?

80 mg Signup and view all the answers

Study Notes

Special Packaging Requirements for Hazardous Substances

Special packaging is mandated to protect children from serious injuries and illnesses caused by handling or ingesting certain hazardous substances.
Packaging must comply with requirements outlined in § 1700.20(a) to ensure safety and prevent accessibility to children.

Specific Substances and Packaging Rules

Aspirin: Must be packaged according to § 1700.15(a), (b), (c) unless it is effervescent tablets with ≤15% aspirin or unflavored powder forms under specific conditions.
Furniture Polish: Nonemulsion types with ≥10% mineral seal oil or petroleum distillates need special packaging, excluding pressurized spray containers.
Methyl Salicylate: Liquid products with >5% weight must adhere to special packaging rules unless in spray containers.
Controlled Drugs: Any drug that includes controlled substances must meet packaging standards for oral formulations.
Sodium & Potassium Hydroxide: Household products with ≥10% sodium or potassium hydroxide must have special packaging.
Turpentine: Liquid forms with ≥10% turpentine require adherence to specific packaging rules.
Kindling Preparations: Liquid preparations with ≥10% petroleum distillates must be packaged appropriately.
Methyl Alcohol: Liquids containing ≥4% must meet special packaging criteria, exempting spray containers.
Sulfuric Acid: Requires special packaging if containing ≥10%, excluding wet-cell batteries.
Prescription Drugs: Oral drugs requiring prescriptions have specific packaging rules, with exceptions for certain formulations like sublingual tablets and some contraceptives.

Additional Hazardous Materials

Ethylene Glycol: Liquids with ≥10% must comply with special packaging regulations.
Iron-Containing Drugs: Products with ≥250 mg elemental iron must meet special packaging requirements, except specific exclusions.
Dietary Supplements with Iron: Supplements with ≥250 mg of elemental iron also need to be specially packaged.
Paint Solvents: Solvents with ≥10% weight of specific volatile substances require special packaging.
Acetaminophen: Oral preparations containing >1g must adhere to special packaging rules but have exceptions for low-dose forms.
Diphenhydramine: Products with >66 mg require packaging compliance since February 11, 1985.
Glueremovers: Liquid forms containing >500 mg acetonitrile need special packaging.

Further Considerations

Naproxen and Ibuprofen: Preparations with ≥250 mg of naproxen or ≥1g ibuprofen must comply with packaging regulations.
Fluoride Products: Household substances with >50 mg of elemental fluoride or >0.5% concentration require special packaging.
Minoxidil: Preparations containing >14 mg must be packaged to prevent child access, including any applicators that may be reused.

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Description

This quiz covers regulations concerning substances that require special packaging to protect children from potential hazards. Explore the requirements and definitions outlined to ensure safety from serious injuries or illnesses. Test your understanding of the rules and their implications.