Label: HYDROGEN PEROXIDE- hydrogen peroxide solution
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Contains inactivated NDC Code(s)
NDC Code(s): 76384-007-01 - Packager: Worldwide Sales & Distribution Corp.
- Category: HUMAN OTC DRUG LABEL
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 August 25, 2011
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
First aid antiseptic
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•let dry first before using bandage
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 doctor or dentist
• children under 2 years of age: consult a dentist or doctor
• children under 12 years of age should be supervised in the use of this product
- GENERAL PRECAUTIONS
- INACTIVE INGREDIENT
- Package Label
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76384-007 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 kg in 100 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76384-007-01 .473 L in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/25/2011 Labeler - Worldwide Sales & Distribution Corp. (627014330) Establishment Name Address ID/FEI Business Operations Steller Mercantile Pvt. Ltd. 650493005 manufacture