3% HYDROGEN PEROXIDE- hydrogen peroxide liquid 
MBS Medical Technologies, Inc.

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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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.

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 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.

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 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 dentist or doctor.

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

Antiseptic

* For treatment of minor cuts and abrasions.

* Oral debriding agent.

* Use as a gargle or rinse.

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

Packaging

3% H2O2

3% HYDROGEN PEROXIDE 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79590-001
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:79590-001-00475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/15/2020
Labeler - MBS Medical Technologies, Inc. (117581535)
Registrant - MBS Medical Technologies, Inc. (117581535)
Establishment
NameAddressID/FEIBusiness Operations
MBS Medical Technologies Inc117581535manufacture(79590-001)

Revised: 9/2020
Document Id: af622d94-71e5-3f57-e053-2995a90abb8c
Set id: af622cd6-fb9d-d32e-e053-2a95a90a2919
Version: 1
Effective Time: 20200915
 
MBS Medical Technologies, Inc.