Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid
- NDC Code(s): 53441-268-16
- Packager: National Distribution Network (Smart Choice)
- 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.
Updated December 26, 2018
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- Active ingredient
For external use only.
Stop use and ask a doctor if
- the condition persists or gets worse
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
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 doctor or dentist
- adults and children 2 years of age and over:
- For use as a first aid antiseptic:
- Other information
- Inactive ingredient
Principal Display Panel
First Aid Antiseptic
FL OZ (mL)
National Distribution Network
P.O Box 875
Melville, NY 11747-0875
Questions or Comments?
Monday-Friday 9AM-5PM EST
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
- Package Label
INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE 3 PERCENT
hydrogen peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53441-268 Route of Administration TOPICAL 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53441-268-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2014 12/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 10/31/2014 12/31/2021 Labeler - National Distribution Network (Smart Choice) (045099210)