Label: NEWRAIN HAND SANITIZER- alcohol gel

  • NDC Code(s): 56136-312-01, 56136-312-02, 56136-312-03
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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 April 30, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 75% ±5%

  • Purpose

     Antiseptic

  • Use(s)

    Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

    Flammable. Keep product away from fire or flame.

    When using this prouct do not use in or near the eye. In case of contact, rine eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation or redness develops and persists.

    Other Information:

    store between 15-30℃ (59-86℉)

    avoid freezing and excssive heat above 40℃（104℉）.

    Keep out of reach of children.

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

    Warning choking Hazard: Small Parts. Not intended for children under 3 years of age.

  • Directions

    Wet hands thoroughly with product and rub hands together until dry.

  • Inactive ingredients

    Alcohol Denat, Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    NEWRAIN HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-312-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    2NDC:56136-312-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    3NDC:56136-312-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/30/2020
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Registrant - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-312)
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