Label: CARE ON HAND SANITIZER GEL- alcohol gel

  • 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 November 19, 2020

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  • Active Ingredients

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • When using this product

    keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using care on Hand Sanitizer gel.
  • Other information

    • Store below 33.8-86F(1-30C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Extract, Rosemary Extract

  • Package Label

    500ml NDC: 70416-2001-1

    100ml NDC: 70416-2001-2

  • INGREDIENTS AND APPEARANCE
    CARE ON HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70416-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LICORICE (UNII: 61ZBX54883)  
    ROSEMARY (UNII: IJ67X351P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70416-2001-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/28/2020
    2NDC:70416-2001-2100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/28/2020
    Labeler - WELCRON HEALTHCARE CO., LTD (688301944)
    Registrant - Devolver Cosmetics Co., Ltd (695733244)
    Establishment
    NameAddressID/FEIBusiness Operations
    Devolver Cosmetics Co., Ltd695733244manufacture(70416-2001)
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