Label: CARE PLUS HAND SANITIZER 16OZ- 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 June 17, 2020

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  • Drug Facts Active ingredient

    Ethyl Alcohol 62 percent

  • Purpose

    Antimicrobial

  • Uses

    hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only.

    Flammable. Keep away from heat and flame.

  • When using this product,

    avoid contact with face, eyes and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

    Stop use and ask a doctor if irritation or redness develops.

  • Keep out of reach for children.

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

  • Directions

    • wet hands thoroughly with product and rub into skin until dry.
    • Children under 6 years of age should be supervised by an adult when using this product.
  • Inactive ingredients:

    Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CARE PLUS HAND SANITIZER 16OZ 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69950-026
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69950-026-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2020
    Labeler - OSTL, INC. (020117798)
    Registrant - OSTL, INC. (020117798)
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