Label: LUCKY SUPER SOFT HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid
- NDC Code(s): 20276-300-16
- Packager: Delta Brands Inc
- Category: HUMAN OTC DRUG LABEL
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 December 16, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only (as a first aid antiseptic).
Do not use
in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
Stop use and consult a doctor if
the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.
As oral debriding agent:
Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or swelling, rash, or fever develops, see your dentist or doctor promptly
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Directions
for use as a first aid antiseptic: Clean the affected area. Apply a small amount of this product on affected area 1to 3 times a daily.
May be covered with a sterile bandage. If bandaged, let dry first
For use as an oral debriding agent:
Adults and children 2 years of age and older: Mix with an equal amount of warm water. Swish around in the mouth over 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 ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
LUCKY SUPER SOFT HYDROGEN PEROXIDE 3 PERCENT
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20276-300 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:20276-300-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/02/2021 Labeler - Delta Brands Inc (102672008)