Label: CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E- ethyl 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 July 8, 2011

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62 PERCENT
  • PURPOSE

    ANTIMICROBIAL

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE.  RECOMMENDED FOR REPEATED USE.

  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR RASH DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    PLACE ENOUGH PRODUCT IN YOUR PALM TO COVER YOUR HANDS. RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

  • INACTIVE INGREDIENTS

    WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER,

    FRAGRANCE, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

  • PRINCIPAL DISPLAY PANEL

    image of label
  • INGREDIENTS AND APPEARANCE
    CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-223-0259 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/08/2011
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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