Active Ingredient
Hydrogen peroxide 3%
Hydrogen Peroxide Liquid
FDA Label NDC 68196-268
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sam's West, Inc for the product Hydrogen Peroxide (NDC 68196-268). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
first aid antiseptic/oral debriding agent
Uses
- first aid to help prevent the risk of infection in minor cuts, scrapes and burns
- aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Warnings
For external use only.
Do Not Use
- in the eyes or apply over large areas of the body
- longer than one week
Ask A Doctor Before Use If You Have
- deep or puncture wounds, animal bites or serious burns
Stop Use And Ask A Doctor If
- the condition persists or gets worse
- sore mouth symptoms do not improve in 7 daysÂ
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
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
- 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 dentistÂ
For use as an oral debriding agent (oral rinse):
Other Information
- keep tightly closed and in a dark place at room temperature.
- do not shake bottle. Hold away from face when opening.
Inactive Ingredient
purified water
Principal Display Panel
Helps prevent the risk of infection
Hydrogen peroxide 3% USP
first aid antiseptic
oral debriding agent
- for use as a gargle or rinse
- For treatment of minor cuts and abrasions
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
For comments or suggestions, call us toll-free at 1-877-753-3935 Monday-Friday 9:00AM-5:00PM EST
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
FL OZ (mL)
DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716
Package Label
Member's Mark hydrogen Peroxide 3% USP
* Please review the disclaimer below.
