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.

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Pharmacy's Prescription 16OZ Hydrogen Peroxide

Active Ingredient

Active ingredient (by volume)

Hydrogen peroxide 3%

Purpose

First aid antiseptic/oral debriding agent.

Warnings

Warnings

For external use only.

Stop Use

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

Keep out of reach of children

Keep this and all drugs out of the reach of children. If swallowed, seek professional or contact a Poison Control Center immediately.

Directions

Directions

First aid antiseptic:

Clean affected area; apply small amount of product on affected area 1-3 times a day; may be covered with a sterile bandage; if bandage, let dry first.

Oral debriding agent (oral rinse):

Adults and children 2 years of age and over:

Mix with an equal amount of water; swish around in the mouth over affected area for at least 1 minute and then spit out; use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.

Inactive Ingredients

Inactive ingredient

Purified water, also contains 0.001% Phosphoric acid as a stabilizer.

Indications & Usage Section

Do not use

In the eyes or apply over large areas of the body; longer than one week; on deep or puncture wounds, animal bites, or on serious burns.

Hydrogen Peroxide 01

PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72197-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72197-008-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/31/2018
Labeler - American Consumer Products Corp (081101181)

Revised: 8/2018
Document Id: 72dcacd3-ddc7-a224-e053-2991aa0aa603
Set id: 72dcacd3-ddc6-a224-e053-2991aa0aa603
Version: 1
Effective Time: 20180807
 
American Consumer Products Corp