Label: HYDROGEN PEROXIDE liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80668-313-01, 80668-313-02, 80668-313-03, 80668-313-04 - Packager: UBQ Industries, LLC
- 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 November 23, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Hydrogen Peroxide 3%
- First aid antiseptic debriding agent
- Indications and usage section
- Warnings Section
- Do not use
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions For use as a first aid antiseptic:
• Clean affected area
• If bandaged, let fry first
• Apply small amount of product on affected area 1 – 3 times a day
• May be covered with a sterile bandage
For use as an oral debriding agent (oral rinse):
Adults and children 2 years of age
• Mix with equal amount of water
• Swish around in the mouth over affect 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 doctor or dentist - Other Information
- Inactive Ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80668-313 Route of Administration DENTAL, ORAL, 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 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80668-313-01 18927 mL in 1 PAIL; Type 0: Not a Combination Product 03/20/2020 2 NDC:80668-313-02 946.4 mL in 1 JUG; Type 0: Not a Combination Product 03/20/2020 3 NDC:80668-313-03 473.2 mL in 1 JUG; Type 0: Not a Combination Product 03/20/2020 4 NDC:80668-313-04 236 mL in 1 JUG; Type 0: Not a Combination Product 03/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/20/2020 Labeler - UBQ Industries, LLC (069021187) Registrant - UBQ Industries, LLC (069021187) Establishment Name Address ID/FEI Business Operations UBQ Industries, LLC 069021187 manufacture(80668-313) , relabel(80668-313) , repack(80668-313)
