Label: HYDROGEN PEROXIDE solution
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NDC Code(s):
10565-001-04,
10565-001-08,
10565-001-16,
10565-001-32, view more10565-001-99
- Packager: Hydrox Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
First aid antiseptic:
- clean the affected area
- apply a small amount of product on the area 1 to 3 times daily
- 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
- 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 dentist or doctor
- children under 12 years of age should be supervised in the use of this product
- children under 2 years of age: consult a dentist or doctor
- Other information
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10565-001 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 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:10565-001-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993 2 NDC:10565-001-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993 3 NDC:10565-001-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993 4 NDC:10565-001-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993 5 NDC:10565-001-99 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 09/01/1993 Labeler - Hydrox Laboratories (025164302) Registrant - Hydrox Laboratories (025164302) Establishment Name Address ID/FEI Business Operations Hydrox Laboratories 025164302 manufacture(10565-001) , label(10565-001) , pack(10565-001)
