Label: COTTONWOOD SANITIZER GEL- 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 July 6, 2020

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  • Active Ingredient(s):

    Ethyl Alcohol 65% v/v

  • Purpose :

    Antibacterial

  • Use(s):

    For rinse free hand cleaning when soap and water are not available.

  • Warning:

    For external use only. Flammable. Keep away from heat or flame.

    When using this product: Avoid contact with eyes, ears and mouth. In case of eye contact, rinse with water. Stop use and ask a doctor if irritation or rash occurs, these may be signs of a serious condition.

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

  • Directions:

    Apply to dry hands, rub into skin, no rinsing required.

  • Other Information:

    Store between 15-30C (59-86F)

  • Inactive Ingredients:

    Glycerin, Betaine, Polyacrylamide, Isoparaffin, Laureth-7, Purified Water USP, Fragrance

    Manufactured by Cottonwood Spirits LLC – 7132 N Silver Creek Road, Park City Utah 84098

    DUNS: 080985574 FDA/NDC: 78002

    435-200-9537 info@alpinedistilling.com

  • Principal Display Panel – 500 mL Bottle Label

    COTTONWOORD
    HAND SANITIZER
    WITH ESSENTIAL OILS

    UNSCENTED

    16 OZ – 500 mL

    Principal Display Panel – 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COTTONWOOD SANITIZER   GEL
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78002-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Betaine (UNII: 3SCV180C9W)  
    Polyacrylamide (Crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) (UNII: RHA9LWJ494)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    Laureth-7 (UNII: Z95S6G8201)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78002-101-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    2NDC:78002-101-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    3NDC:78002-101-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    4NDC:78002-101-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2020
    Labeler - Alpine Distilling (080985574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alpine Distilling080985574MANUFACTURE(78002-101)
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