Label: FROSTED CRANBERRY HAND SANITIZER- alcohol gel

  • NDC Code(s): 56136-346-01
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • 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 25, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol Denat. 66% 

  • Purpose

     Antimicrobial

  • Use

    • hand sanitizer to help Decreases bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only.

    Flammable. Keep product away from heat or flame.

    Does not contain grain alcohol; do not drink, if taken internally will produce severe gastric disturbances.

    When using this product Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

    Other information

    • Do not store above 105℉
    • May discolor some fabrics

    Keep out of reach of children.

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

  • Directions

    • Rub dime sized amount between hands until dry
    • Supervise children in the use of this product
    • In case of eye contact, rinse eyes thoroughly with water
  • Inactive ingredients

    Water, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol. May contain: D&C Red No. 33, FD&C Red No. 4, FD&C Yellow No. 5, FD&C Blue No. 1.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    FROSTED CRANBERRY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-346
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-346-0129.57 mL in 1 BOTTLE; Type 0: Not a Combination Product06/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/27/2020
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-346)
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