Label: HYDROGEN PEROXIDE solution
- NDC Code(s): 10733-800-08, 10733-800-16
- Packager: MEDICAL PRODUCTS LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- USES
-
WARNINGS
For external use only.
Do not use:
- in the eyes or apply over large areas of the body
- longer than one week
Ask a doctor before use if you have
- deep or puncture wounds, animal bites or serious burns
Stop use and ask a doctor if
- swelling, rash, or fever develops
- the condition persists or gets worse
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
-
Directions
For use as a first aid antiseptic:
- clean affected area
- apply small amount of product on affected area 1-3 times a day
- may be covered with a sterile bandage
- if bandaged, let dry first
For use as an 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 affected area for at least 1 minute and then spit out. Do not swallow.
- use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
children under 12 years should be supervised in the use of this product
children under 2 years of age: consult a dentist or doctor - Other Information
- Keep out of reach of children
- Inactive Ingredients
- TOPICAL SOLUTION FIRST AID ANTISEPTIC ORAL DEBRIDING AGENT
- 10733-800-16
- 10733-800-08
-
INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10733-800 Route of Administration TOPICAL, ORAL 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) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10733-800-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2020 09/30/2022 2 NDC:10733-800-08 236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 11/16/2020 Labeler - MEDICAL PRODUCTS LABORATORIES, INC. (002290302)