HUMCO HYDROGEN PEROXIDE- hydrogen peroxide 3% liquid 
Humco Holding Group, 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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Private Label Hydrogen Peroxide 3%, USP

Drug Facts

Active Ingredient

Hydrogen Peroxide 3%

Purpose

Antiseptic

Uses

As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

As an oral rinse for temporary use in cleaning of minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.

Warnings

For external use except when used as an oral rinse.

Do not use in the eyes.

Do not apply over large areas of the body.

Do not use longer than 1 week unless directed by a dentist or doctor.

Ask a doctor before use if you have:

deep or puncture wounds, animal bites, serious burns.

Stop use consult a dentist or doctor if:

condition persists or gets worse, sore mouth symptoms do not improve in 7 days, irritation, pain, redness or fever develop.

Keep out of reach of children.

In case of acciedntal ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

For antiseptic use: Clean the affected area, apply a small amount on the area 1 to 3 times daily.

For oral rinse use: Adults and children 2 years and older mix with an equal amount of water and swish around and over the affected area then spit out. Use up to 4 times daily or as directed by a dentist or a doctor.

Children under 2 years of age: consult a doctor.

Other information

Keep tightly closed and at controlled room temperature 15-30C (59-86F).

Do not shake.

Inactive ingredient

Purified water

Good Neighbor Label

GNP

Sunmark Label

SMH2O2.jpgSunmark

Health Mart Label

HMH2O2.jpgHM

HUMCO HYDROGEN PEROXIDE 
hydrogen peroxide 3% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9116
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:0395-9116-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2017
2NDC:0395-9116-94113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2017
3NDC:0395-9116-98237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/25/1998
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884label(0395-9116) , manufacture(0395-9116) , pack(0395-9116) , analysis(0395-9116)

Revised: 6/2020
Document Id: a883f0c0-7c23-1de7-e053-2995a90ac89b
Set id: 6062c42c-7a43-ecbf-e053-2a91aa0a55f8
Version: 3
Effective Time: 20200620
 
Humco Holding Group, Inc.