Label: BENEMAX ADVANCED HAND SANITIZER- hydrogen peroxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 73700-003-01 - Packager: Nugale Pharmaceutical 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 March 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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Warnings
For external use only. Do not use: In the eyes over large areas of the body, or for longer than 1 week. Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
Stop use immediately and consult your physician if: The condition persists or worsens after use. If sore mouth symptoms do not improve in 7 days, If irritation, pain or redness persist or worsen. If swelling, rash or fever develop.
- Uses
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Directions
• clean the affected area • apply a small amount of product on affected area 1 to 3 times a day • may be covered with a sterile bandage • if
bandaged, let dry first • 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 before use. - Keep out of reach of children
- Inactive ingredient
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Other information
Keep tightly closed in a cool dark place • Do not shake bottle • Hold away from face when opening.
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. - Product label
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INGREDIENTS AND APPEARANCE
BENEMAX ADVANCED HAND SANITIZER
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73700-003 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:73700-003-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/25/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/25/2021 Labeler - Nugale Pharmaceutical Inc (202595872) Establishment Name Address ID/FEI Business Operations Nugale Pharmaceutical Inc 202595872 manufacture(73700-003)
