Hydrogen Peroxide 3 Percent: Package Insert and Label Information

HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid
Sam’s West, Inc

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.

Active ingredient

Hydrogen peroxide 3%

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 days
• 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

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

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

HYDROGEN PEROXIDE 3 PERCENT hydrogen peroxide liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-268 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE 2.65 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68196-268-32 946 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/30/2014

Labeler — Sam’s West, Inc (051957769)

Revised: 05/2023 Sam’s West, Inc