Label: SMART SENSE HYDROGEN PEROXIDE- hydrogen peroxide cloth

  • 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.

Drug Label Information

Updated October 3, 2011

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    Smart Sense

    3% Hydrogen Peroxide Wipes

    Topical Solution, USP

    First Aid Antiseptic

    For Treatment of Minor Cuts and Scrapes

    CAUTION
    KEEP OUT OF REACH OF CHILDREN

    40 Wipes

    7.0" X 5.75"

  • DRUG FACTS

    Active Ingredients

    Hydrogen Peroxide (stabilized) 3%

  • PURPOSE

    Purpose

    First aid antiseptic

  • INDICATIONS & USAGE

    Use - first aid to help prevent the risk of infection in; - minor cuts - scrapes - burns

  • WARNINGS

    For external use only

  • ASK DOCTOR

    Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

  • DO NOT USE

    Do not use - in eyes or over large areas of the body - longer than 1 week unless directed by a doctor

  • STOP USE

    Stop use and ask a doctor if

    - condition persists or gets worse

    - irritation, pain, or redness persists

    - swelling, rash, or fever develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

    at (1-800-222-1222). Do not get in eyes.

  • DOSAGE & ADMINISTRATION

    Directions - clean the affected area - apply product on the affected area 1 to 3 times a day

    - may be covered with a sterile bandage - if bandaged, let dry first

  • STORAGE AND HANDLING

    Other information. Do not apply internally. Keep canister tightly closed and at a controlled room temperature

    150 - 300C (580 - 860F). Hold away from face when opening. Protect from light.

  • INACTIVE INGREDIENT

    Inactive ingredients purified water

  • PRINCIPAL DISPLAY PANEL

    Made in USA

    Distributed by:

    Kmart Corporation

    Hoffman Estates. IL 60170

    Shop kmart.com

  • PRINCIPAL DISPLAY PANEL

    Hydrogen Peroxide Wipes Label

  • INGREDIENTS AND APPEARANCE
    SMART SENSE HYDROGEN PEROXIDE 
    hydrogen peroxide cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52553-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52553-002-01238 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2011
    Labeler - US Nonwovens (847061520)
    Establishment
    NameAddressID/FEIBusiness Operations
    US Nonwovens847061520manufacture, label, pack, analysis