Label: HYDROGEN PEROXIDE solution
- NDC Code(s): 63517-450-26, 63517-450-34, 63517-450-43
- Packager: Cardinal Health
- 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 September 12, 2023
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- Official Label (Printer Friendly)
- 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
NDC 63517-450-43
Hydrogen Peroxide 3%
first aid antiseptic
oral debriding agent
DO NOT USE IF PACKAGE OPENED OR DAMAGED
TEMPERATURE LIMITATION 68°F - 77°F 20°C - 25°C
Not Made with Natural Rubber Latex
For Individual, Professional, and Hospital Use
Cat. AS-HPL16
Distributed by: Cardinal Health
Waukegan, IL 60085 USA
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2015 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH and the Cardinal Health
LOGO are trademarks of Cardinal Health.
CardinalHealth
16 FL OZ (1 PT) 473 mL
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63517-450 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:63517-450-26 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2015 2 NDC:63517-450-34 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2015 3 NDC:63517-450-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2015 Labeler - Cardinal Health (961027315) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63517-450) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63517-450)