OTC Medication Information: Pharmacys Prescription Hydrogen Peroxide

PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE- hydrogen peroxide liquid
American Consumer Products Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Active Ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

Purpose

First aid antiseptic. Oral debriding agent.

Uses

Uses — first aid to help prevent the risk of infection in minor cuts, scrapes and burns. Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

Warnings

Warnings For external use only.

Do not use

Do not use in the eyes, or apply over large ares of the body longer than 1 week.

Ask a doctor

Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

Stop use

Stop use and ask doctor if • the condition persists or gets worse • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash, or fever develops.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Directions.

First aid antiseptic: • clean the affected area • apply small amount of product on the affected area 1 to 3 times a day • may be covered with sterile bandage • if bandaged, let dry first.

Oral debriding agent: adults, children over 2 years of age: • mix with equal amount of water • swish around in the mouth over the affected area for at least 1 minute, then spit out • use up to 4 times daily after meals and at bedtime • children under 12 years of age should be supervised in the use children under 2 years of age: consult a dentist, doctor

Other information

Other information keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

Inactive ingredient: purified water.

Distributed by

Distributed By:

American Consumer Products Corp.

Vernon, CA 90058

Label

PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE hydrogen peroxide liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72197-038 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE 3 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72197-038-16 473.17 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/14/2020

Labeler — American Consumer Products Corp (081101181)

Revised: 09/2020 American Consumer Products Corp