NDC | 53033-003-01, 53033-003-02, 53033-003-03, 53033-003-04, 53033-003-05, 53033-003-06, 53033-003-07, 53033-003-08, 53033-003-09, 53033-003-10, 53033-003-11 |
Set ID | 3faa36a2-3d15-42a2-a03e-a76ef4e5d506 |
Category | HUMAN OTC DRUG LABEL |
Packager | Pioneer Associates |
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 affected area
- apply small amount of product on affected area 1-3 times a day
- may be covered with a sterile bandage
- if bandaged, let dry first
oral debriding agent (oral rinse):
- 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 solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53033-003 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:53033-003-08 100 mL in 1 BOTTLE, PLASTIC 2 NDC:53033-003-01 119 mL in 1 BOTTLE, PLASTIC 3 NDC:53033-003-02 178 mL in 1 BOTTLE, PLASTIC 4 NDC:53033-003-09 200 mL in 1 BOTTLE, PLASTIC 5 NDC:53033-003-03 237 mL in 1 BOTTLE, PLASTIC 6 NDC:53033-003-10 250 mL in 1 BOTTLE, PLASTIC 7 NDC:53033-003-11 266 mL in 1 BOTTLE, PLASTIC 8 NDC:53033-003-04 295 mL in 1 BOTTLE, PLASTIC 9 NDC:53033-003-05 354 mL in 1 BOTTLE, PLASTIC 10 NDC:53033-003-06 414 mL in 1 BOTTLE, PLASTIC 11 NDC:53033-003-07 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/24/2012 Labeler - Pioneer Associates (012604336) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(53033-003)