BERKLEY JENSEN ANTISEPTIC- hydrogen peroxide liquid 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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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Berkley Jensen 3% Hydrogen Peroxide

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.

Ask a doctor before use if you have deep or 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 poison control center right away.

stop use

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.

Ask doctor 

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

Do not use

Do not use *in the eyes or apply over large areas of the body. *longer than one week.

Directions For use as a first aid antiseptic:

Other information

Inactive ingredient purified water

Packaging

2

BERKLEY JENSEN  ANTISEPTIC
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76772-028-95946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2021
Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Establishment
NameAddressID/FEIBusiness Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-028)

Revised: 6/2021
Document Id: c579430b-0154-0e11-e053-2995a90a4fd1
Set id: c579430b-0153-0e11-e053-2995a90a4fd1
Version: 1
Effective Time: 20210623
 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI