Label: HAND SANITIZER- 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 December 29, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Aqua, Camellia Sinensis Leaf Oil, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Parfum.

  • Purpose

    Antiseptic

  • Use

    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 away from fire or flame.

  • Do not use

    • On children less than 2 months of age.
    • On open skin wounds.
  • WHEN USING

    Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F).
    • Avoid freezing and excessive heat above 40C (104F).
  • Questions or Comments?

    Call 1-888-463-6332 Monday-Friday 9AM-5PM EST FDA NDC Product Code: 76741-003-12

  • Package Label - Principal Display Panel

    120 ml NDC:76741-003-12 Lavender Label ALavender Label B

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76741-003
    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
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76741-003-12120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/19/2020
    Labeler - Sutra Beauty Inc (040228928)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Joy Claire Biological Technology Co.,Ltd418209894manufacture(76741-003)
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