Label: PREVENT HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide spray
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Contains inactivated NDC Code(s)
NDC Code(s): 78835-007-01 - Packager: Eco-Med Pharmaceuticals, Inc.
- 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 October 29, 2020
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- DRUG FACTS
- ACTIVE INGREDIENT
- USES:
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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.
When using this product:
Do not get into eyes. Do not apply over large areas of the body. Do not use longer than one week unless directed by a doctor .
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DIRECTIONS:
For first aid antiseptic use: 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 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:
- INACTIVE INGREDIENT:
- Questions:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PREVENT HYDROGEN PEROXIDE 3 PERCENT
hydrogen peroxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78835-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 0.03 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78835-007-01 24 in 1 BOX 10/15/2020 1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/15/2020 Labeler - Eco-Med Pharmaceuticals, Inc. (249183435)