Label: BLOSSOM HP 3- hydrogen peroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61767-306-01, 61767-306-02 - Packager: Blossom Pharmaceuticals
- 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 January 31, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
DIRECTIONS as a First Aid Antiseptic:
- clean the affected area
- apply a small amount of this product on the affected area 1 to 3 times a day
- may be covered with a sterile bandage
- if bandaged let dry first
DIRECTIONS as a Oral Debriding Agent:
Adults, children over 2 years of age:
- mix with an equal amount of water
- swish around the mouth in 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 dentis or doctor
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BLOSSOM HP 3
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61767-306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 2.65 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:61767-306-01 118 mL in 1 BOTTLE 2 NDC:61767-306-02 454 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/29/2014 Labeler - Blossom Pharmaceuticals (677381470) Establishment Name Address ID/FEI Business Operations Blossom Pharmaceuticals 677381470 manufacture(61767-306)