Label: HYDROGEN PEROXIDE solution
- NDC Code(s): 61504-871-08, 61504-871-43, 61504-871-72
- Packager: Amerifoods Trading Co
- 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 December 19, 2022
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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.
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Directions
First aid antiseptic:
- clean the affected area
- spray a small amount of product on the affected area 1 to 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 an equal amount of water
- swich 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 ago should be supervised in the use
- children under 2 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- adverse reactions
-
principal display panel
61504-871-43
Iris
Hydrogen
Peroxide
TOPICAL SOLUTION USP
First Aid Antiseptic/
Oral Debriding Agent
For Treatment of
Minor Cuts & Abrasions
For use as a gargle or Rinse
Square bottle uses less plastic then a similarly sized round bottle
Recyclable (if available in your area)
DO NOT USE IF PRINTED DEAL UNDER CAP IS BROKEN OR MISSING
NET 16 FL OZ (1PT) 473mL
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61504-871 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:61504-871-08 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/09/2017 2 NDC:61504-871-72 295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/09/2017 3 NDC:61504-871-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/09/2017 Labeler - Amerifoods Trading Co (626388680) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(61504-871) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 088520668 manufacture(61504-871)