Label: HUMCO HYDROGEN PEROXIDE- hydrogen peroxide 3% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0395-9116-16, 0395-9116-94, 0395-9116-98 - 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.
Drug Label Information
Updated June 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- SPL UNCLASSIFIED SECTION
- Warnings
- Ask a doctor before use if you have:
- Stop use consult a dentist or doctor if:
- Keep out of reach of children.
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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
- Inactive ingredient
- Good Neighbor Label
- Sunmark Label
- Health Mart Label
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INGREDIENTS AND APPEARANCE
HUMCO HYDROGEN PEROXIDE
hydrogen peroxide 3% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9116 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:0395-9116-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017 2 NDC:0395-9116-94 113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017 3 NDC:0395-9116-98 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2015 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(0395-9116) , manufacture(0395-9116) , pack(0395-9116) , analysis(0395-9116)