Label: STERITOUCH ANTISEPTIC HAND SANITIZER WITH VITAMIN E- 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 November 5, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 73% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin

    • recommended for repeated use

    • when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use 

    • in children less than 2 months of age

    • on open skin wounds

    When using this product

    • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop

    • condition persists for more than 72 hours

    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 and allow to dry without wiping

    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)

    • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    Water, Carbomer, Fragrance, Glycerine, Tocopheryl Acetate, Propylene Glycol, Triethanolamine

  • QUESTIONS

    Questions? +1-801-392-0937

    You may also report serious side effects to this phone number.

    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Distributed by: S.K.P. LLC, 2105 s 1100 W, West Haven, UT 84401

    COUNTRY OF ORIGIN: INDIA

    Manufactured by: WELABLE HEALTHCARE(INDIA)

    E-Mail: info@welable.com

  • Packaging

    IMAGE

    IMAGEIMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    STERITOUCH ANTISEPTIC HAND SANITIZER WITH VITAMIN E 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78020-334
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78020-334-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    2NDC:78020-334-0380 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    3NDC:78020-334-0489 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    4NDC:78020-334-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    5NDC:78020-334-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    6NDC:78020-334-16499.79 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    7NDC:78020-334-341005 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    8NDC:78020-334-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/26/2020
    Labeler - WELABLE HEALTHCARE (878839111)
    Establishment
    NameAddressID/FEIBusiness Operations
    WELABLE HEALTHCARE878839111manufacture(78020-334)
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