Label: HYDROGEN PEROXIDE liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52862-007-02, 52862-007-03, 52862-007-04, 52862-007-05, view more52862-007-06, 52862-007-07, 52862-007-08, 52862-007-09, 52862-007-10, 52862-007-11, 52862-007-12 - Packager: Home Smart Products
- 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 December 31, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
first aid antiseptic:
- clean the affected area
- apply small amount of product on the affected area 1-3 times a day
- may be covered with a sterile bandage
- if bandaged, let dry first
oral debriding agent:
- adults and children 2 years of age and over:
- mix with equal amount of water
- swish around in the mouth over the affected area for at least 1 minute and then spit out
- use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
- children under 12 years of age should be supervised in the use of this product
- children under 2 years of age: consult a dentist or doctor
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52862-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 3 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52862-007-02 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 2 NDC:52862-007-03 119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 3 NDC:52862-007-04 178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 4 NDC:52862-007-05 200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 5 NDC:52862-007-06 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 6 NDC:52862-007-07 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 7 NDC:52862-007-08 266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 8 NDC:52862-007-09 295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 9 NDC:52862-007-10 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 10 NDC:52862-007-11 414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 11 NDC:52862-007-12 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/08/2012 Labeler - Home Smart Products (161872676) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52862-007)
