Label: ACP HAND SANITIZER- ethyl alcohol gel

  • 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 June 26, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Uses

    • Hand sanitizer to reduce microorganisms on the skin.
    • Use this product when soap and water are not available.

  • Warnings

    • For external use only. • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • FLAMMABLE. This product contains ethyl alcohol. Keep away from sources of ignition. • Discontinue use if irritation or redness develops. • If irritation persists for more than 72 hours, consult a physician. 

    • KEEP OUT OF REACH OF CHILDREN. 

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

  • Directions

    • Read the entire label before using this product.
    • Place enough product on your palm to thoroughly cover your hands.
    • Rub hands together briskly until dry.

  • Inactive Ingredients

    Water, Glycerine, 1,2 Propylene Glycol, Carbomer, 2-Amino-2-Methyl Propanol

  • SPL UNCLASSIFIED SECTION

    70% Alcohol
    Self Drying Gel
    Rub well until dry

    Distributed & Marketed by Swanrose Inc.
    SWANROSE, INC.
    751 N. SPAULDING AVENUE
    LOS ANGELES, CA 90046
    PHONE: +1 (310) 266-5812
    Made in China

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ACP HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78287-120
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78287-120-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    2NDC:78287-120-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    3NDC:78287-120-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    4NDC:78287-120-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    5NDC:78287-120-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    6NDC:78287-120-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    7NDC:78287-120-07560 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    8NDC:78287-120-08980 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    9NDC:78287-120-092000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    10NDC:78287-120-104000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/24/2020
    11NDC:78287-120-115000 mL in 1 CAN; Type 0: Not a Combination Product06/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/24/2020
    Labeler - Swanrose, Inc. (117523391)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD529558167manufacture(78287-120)
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