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USA regulations on child resistant packaging

Aug 15 , 2022

Child resistant packaging refers to a form of packaging that is specially designed to prevent children from opening at will in a short period of time. Its purpose is to prevent children from accidentally eating medicines. At present, many countries in the world have formulated standards for this kind of packaging, and the United States is the first country to legislate for this kind of packaging.


USA regulations on child resistant packaging

45ml plastic medicine bottle with CRC

The Poison Prevention Packaging Act (PPPA) has been in place since 1970 with the primary purpose of keeping children safe by preventing accidental ingestion of harmful chemicals. The law requires that items such as prescription drugs, over-the-counter (OTC) medicines, household chemicals, and other hazardous products be in child-resistant packaging. The nature of this packaging will make it inaccessible to children 5 years and younger and provide a protected container. This has been shown to avoid accidental prescription poisoning. This law affects many parties, including children, the elderly and the disabled.

The Poison Preventive Packaging Act (PPPA) stipulates that products harmful to children must be packaged in child resistant packaging. The specific involved drugs and dietary supplements include the following categories:

1. The following human products intended for oral use: aspirin; prescription and controlled drugs; products containing more than 1 gram of paracetamol, and products containing 1 gram or more of ibuprofen; containing more than 66 mg of diphenhydramine equivalent products; and products containing more than 0.045 mg of loperamide;

2. The liquid product contains more than 5% methyl salicylate;

3. Liquids containing 250 mg or more of elemental iron at a concentration of 0.025% or more by weight/volume; for non-liquids, at a concentration of 0.05% or more by weight/weight;

4. Products containing more than 5 mg of lidocaine or 0.5 mg of dibucaine; e) products for human use containing 250 mg or more of naproxen or more than 50 mg of ketoprofen;

5. Fluoride-containing products and ethanol-containing mouthwashes. (See description above.);

6. Human products containing more than 14 mg of minoxidil;

7. Any dosage form available orally available over-the-counter (OTC) and containing an active ingredient that was previously only available by prescription.

8. Products containing imidazoline equal to or greater than 0.08 mg.

The above are the relevant regulations on child resistant packaging in the United States. This regulation protects children's safety and greatly reduces the serious consequences of children's accidental ingestion of medicines.


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