Label: NAKED NATURALS 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 June 25, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    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 heat or flame.

    Do not use

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

    When using this product

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

    Stop use and seek a doctor

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

    Keep out of reach of children.

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

  • 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 ingestion.

  • Other information

    • Store between 15-30C (59-86F).
    • Avoid freezing and excessive heat above 40C (104F).
  • Inactive ingredients

    Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Tocopheryl Acetate, Blue 1 (CI 42090).

  • Questions?

    call 888 387 3887

  • Company Information

    Dist: Welburn Corporation

    PO BOX 1392

    Hermosa Beach, CA 90254

    Made in Guatemala

  • Product Packaging - 500ml

    ADVANCED FORMULA!

    NAKED

    NATURALS

    HAND SANITIZER

    WITH VITAMIN E

    NON STERILE SOLUTION

    ALCOHOL 70%

    16.9 fl. oz. / 500ml

    vitamin e sanitizer

  • INGREDIENTS AND APPEARANCE
    NAKED NATURALS HAND SANITIZER WITH VITAMIN E 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77622-007
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77622-007-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    2NDC:77622-007-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    3NDC:77622-007-04236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    4NDC:77622-007-03280 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    5NDC:77622-007-05458 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    6NDC:77622-007-061000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    7NDC:77622-007-072000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    8NDC:77622-007-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    9NDC:77622-007-091000000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/25/2020
    10NDC:77622-007-10500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/25/2020
    Labeler - Welburn Corporation (117515830)