Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid
- NDC Code(s): 55315-268-16, 55315-268-32
- Packager: Freds 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.
Updated February 28, 2019
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- Active ingredient
For external use only.
Stop use and ask a doctor if
- Swelling, rash, or fever develops
- the condition persists or gets worse
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
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 dentist or doctor
- Other information
- Inactive ingredient
Princiapl Display Panel
FIRST AID ANTISEPTIC
ORAL REBRIDING AGENT
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: fred's Inc.
4300 NEW GETWELL RD.
Questions or comments?
- Package Label
INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE 3 PERCENT
hydrogen peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-268 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:55315-268-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/2014 2 NDC:55315-268-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/31/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 12/31/2014 Labeler - Freds Inc (005866116)