Label: HAND SANITIZER POMEGRANATE AND VANILLA 3OZ- alcohol liquid

  • 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 February 23, 2021

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antimicrobial

  • Use

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only. Flammable, keep away from heat or flame

  • Do not use

    • in the eyes. In case of contact, rinse eyes thoroughly with water.
  • STOP USE

    Stop use and ask a doctor if irritation or rednees develp and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product
    • briskly rub hands together until dry.
    • Supervise children under 6 years of age when using this product.
  • Other information

    • Store at room temperature
    • may discolor certain fabrics
  • Inactive ingredients

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate, d&c red no.33.

  • QUESTIONS

    1-855-345-5575

  • Package Label - Principal Display Panel

    BottleBox

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER POMEGRANATE AND VANILLA  3OZ
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-165
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-165-011 in 1 BOX02/23/2021
    188.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/23/2021
    Labeler - China Ningbo Shangge Technology Co., Ltd. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Technology Co., Ltd.529287434manufacture(58503-165)
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