NDC | 41520-942-34, 41520-942-43, 41520-942-45, 41520-942-50, 41520-942-99 |
Set ID | 1d9bacfd-2739-4948-98e3-d90323db9c7a |
Category | HUMAN OTC DRUG LABEL |
Packager | FOODHOLD U.S.A., LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- Active ingredient
- Purpose
- Use
- Warnings
- Do not use
- Ask a doctor before use if you have
- Stop Use and ask a doctor if
- Keep out of reach of children.
-
Directions
First Aid Antiseptic:
- clean the affected area
- apply a small amount of the product on the affected area 1 to 3 times a day
- may be covered with a sterile bandage
- if bandage, let dry first
Oral Debriding Agent:
- adults, children over 2 years of age
- mix with equal amount of water
- swish around in the mouth over the affected area for at least 1 minute, then spit out
- use up to 4 times daily after meals and at bedtime
- children under 12 years of age should be supervised in the use
- children under 2 years of age: consult a dentist or doctor
- Other information
- 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:41520-942 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:41520-942-34 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/10/2011 2 NDC:41520-942-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/10/2011 3 NDC:41520-942-50 710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/10/2011 4 NDC:41520-942-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/10/2011 5 NDC:41520-942-99 236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/10/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/10/2011 Labeler - FOODHOLD U.S.A., LLC (809183973) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(41520-942)