Label: HAND SANITIZER WIPES- alcohol 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 August 13, 2020

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

  • Active Ingredient

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame. For external use only, do not inhale or ingest

  • Do not use

    in or near eyes. In case of contact with eyes, rinse thoroughly with water. Avoid contact with broken skin

  • Stop use and ask a doctor if

    irritation or rash develops and persists for more than 72 hours

  • Keep out of reach of children

    If swallowed, get medical help or contact the Poison Control Center immediately.

  • Directions

    • Unfold, and wipe hands thoroughly for about 30 seconds
    • For children under 6, use only under adult supervision
    • Not recommende for infants
    • Dispose of wipe in trash after use. DO NOT flush
  • Other information

    • Store at room temperature (66ºF-77ºF)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Glycerin, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Decyl Glucoside, Benzalkonium Chloride, Cetylpyridinium Chloride, Didecyldimonium Chloride

  • Package Label

    package label

  • Package Label

    container label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76546-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76546-002-15150 in 1 CONTAINER; Type 0: Not a Combination Product05/18/2020
    2NDC:76546-002-0550 in 1 CONTAINER; Type 0: Not a Combination Product05/18/2020
    3NDC:76546-002-5050 in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    4NDC:76546-002-1010 in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/18/2020
    Labeler - Southern Telecom, Inc. (169110033)