NDC | 52862-007-02, 52862-007-03, 52862-007-04, 52862-007-05, 52862-007-06, 52862-007-07, 52862-007-08, 52862-007-09, 52862-007-10, 52862-007-11, 52862-007-12 |
Set ID | 5c8f7727-5f21-4a69-8af1-c24b43571d4d |
Category | HUMAN OTC DRUG LABEL |
Packager | Home Smart Products |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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)