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Oral care
All Containers›Shop by use case›Oral care›Two entries, and one specifies the pumpShop all oral care →
Oral care

Two entries, and one specifies the pump

By Dwight Davis, Founder

Updated

On this page6
A mouthwash at 3 g or more of ethanol per package needs child-resistant packaging unless it has a nonremovable pump that meters no more than 0.03 grams of ethanol per actuation. A fluoride product is caught at 50 mg per package together with a concentration test. Both rules have the package inside them.

Getting started

Before the first batch.
Is this for you at allFrom formula to bottle

Two entries

Ethanol, fluoride, and the pump.
Ethanol, and 3 grams per packageThe pump exemptionFluoride, two tests

Cosmetic or drug

The anticaries monograph.
The anticaries monographThe required warning

What goes wrong

Named failures, with the cause for each.
The exemption was not availableA travel size changed the answerA claim made it a drugThe pump or the liner failed

Containers

443 bottles, and no nonremovable pump.
What we actually stock for thisPumps and closures

Tools and directories

Things to use rather than read.
The check, before the first batch
Written from 16 CFR 1700.14(a)(22), (a)(27) and 21 CFR 355.50. Every page names its source.