HYDROGEN PEROXIDE- hydrogen peroxide liquid 
Universal Distribution Center 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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Hydrogen peroxide Topical Solution USP 3%

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

Directions For use a 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

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 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

Topical Solution USP 3%

First Aid Antiseptic/Oral Debriding Agent

For Treatment of Minor Cuts & Abrasions

For Use As a Gargle or Rinse

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

Distributed by:

Universal Distribution Center

96 Distribution Boulevard

Edison, NJ 08817

Made in India

Packaging

IMAGE

HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-025-40100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
2NDC:52000-025-41119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
3NDC:52000-025-42178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
4NDC:52000-025-43200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
5NDC:52000-025-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
6NDC:52000-025-44250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
7NDC:52000-025-45266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
8NDC:52000-025-31295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
9NDC:52000-025-32354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
10NDC:52000-025-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
11NDC:52000-025-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/25/2015
Labeler - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
BIOTEK INDIA675484458manufacture(52000-025)

Revised: 10/2020
Document Id: 06c02867-b655-4fa4-898c-f0bb56487981
Set id: 091bea0c-7582-45d7-b04e-7d49d7fc4648
Version: 2
Effective Time: 20201022
 
Universal Distribution Center LLC