Hydrogen Peroxide by American Consumer Products, LLC Drug Facts

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by American Consumer Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid 
American Consumer Products, LLC

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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Drug Facts

Active ingredient

 Hydrogen peroxide 3%

Purpose

 First aid antiseptic/oral debriding agent

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

For external use only.

Do not use

  • in the eyes or apply over large areas of the body
  • longer than one week

Ask a doctor before use if you have

  • deep puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

  • swelling, rash, or fever develops
  • the condition persists or gets worse
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

​Directions

For use as a first aid antiseptic:

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

For use as an 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 it out. Do not swallow.
    • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • children under 12 years should be supervised in the use of this product
  • children under 2 years of age: consult a doctor or dentist 

Other information

  • keep tightly closed and in a dark place at room temperature
  • do not shake bottle. Hold away from face when opening

Inactive ingredient

purified water 

Principal Display Panel

SOLUTION OF

Hydrogen Peroxide

3% H2O2 USP

TOPICAL ANTI-INFECTIVE

  • For treatment of minor cuts and abrasions.
  • For use as a gargle or rinse.

FL. OZ. (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Exclusively Distributed by:

©American Consumer Products, LLC

Los Angeles, CA, U.S.A.

Questions or comments? Call 1-888-227-4050

Package Label

Hydrogen Peroxide 3%

PHARMACY'S PRESCRIPTION Hydrogen Peroxide 3%

HYDROGEN PEROXIDE  3 PERCENT
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 18027-268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 18027-268-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201612/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/31/201612/31/2019
Labeler - American Consumer Products, LLC (858427334)

Revised: 9/2019
Document Id: 7e9d8498-dca2-451a-9b5c-df86b4eb2cca
Set id: 7dd4e0e5-1631-4fa9-9f82-68f889a66b45
Version: 2
Effective Time: 20190930
 
American Consumer Products, LLC