NDC | 49580-0268-3, 49580-0268-6 |
Set ID | b0866db5-3b0d-4478-9b3b-1f077d2f5393 |
Category | HUMAN OTC DRUG LABEL |
Packager | P & L Development, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- Active ingredient
- Purpose
- Uses
- Warnings
-
Directions
For use as a first aid antiseptic:
- clean affected area
- apply small amount if product on affected area 1-3 times a day
- may be covered with a sterile bandage
- if bandaged, let dry first
For use as an oral debriding agent (oral rinse):
-
adults and children 2 years of age and over:
- mix with an equal amount of water
- swish around in the mouth over affected area for at least 1 minute and then spit it out. Do not swallow.
- use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
- children under 12 years should be supervised in the use of this product
- children under 2 years of age: consult a doctor or dentist
- Other information
- Inactive ingredient
- Principal Display Panel
- Package Label
-
INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE 3 PERCENT READYINCASE
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0268 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:49580-0268-3 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2014 2 NDC:49580-0268-6 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 08/31/2014 Labeler - P & L Development, LLC (101896231)