Label: HUMCO HYDROGEN PEROXIDE- hydrogen peroxide 3% liquid
- NDC Code(s): 0395-1113-16, 0395-1113-18, 0395-1113-94
- Packager: Humco Holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated November 9, 2017
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Hydrogen Peroxide 3%Close
As an antiseptic to help prevent infection in minor cuts, scrapes, burns.Close
- SPL UNCLASSIFIED SECTION
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.Close
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.Close
- Ask a doctor before use if you have:
deep or puncture wounds, animal bites, serious burns.Close
- 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.Close
- Keep out of reach of children.
In case of acciedntal ingestion, seek professional assistance or contact a Poison Control Center immediately.Close
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.Close
- Other information
Keep tightly closed and at controlled room temperature 15-30C (59-86F).
Do not shake.Close
- Inactive ingredient
- Principal package display
Label 16 oz
- New Label
- INGREDIENTS AND APPEARANCE
HUMCO HYDROGEN PEROXIDE
hydrogen peroxide 3% liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-1113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-1113-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017 2 NDC:0395-1113-18 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017 3 NDC:0395-1113-94 113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/25/1998 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding group, Inc. 825672884 label(0395-1113) , manufacture(0395-1113) , pack(0395-1113) , analysis(0395-1113)