Label: AMERICAN SHAMAN HAND SANITIZER- 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 June 25, 2020

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  • Drug Facts

  • Active Ingredients [s]

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Use[s]

    •Hand sanitizer to help reduce bacteria that potentially can 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

    •  in 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 eyes thoroughly 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. If swallowed, 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 swallowing.
  • Other Information

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

    Glycerol, Hydrogen Peroxide, Purified Water USP, Cross Polymer Cellulose, Fragrance.

  • SPL UNCLASSIFIED SECTION

    Alcohol Antiseptic 80%
    Topical Solution
    Non-sterile Solution

    MANUFACTURED BY
    SHAMAN BOTANICALS, LLC    2405 Southwest Blvd.
    Kansas City, MO 64108
    AmericanShamanProducts.com
    855-427-7386

  • SPL UNCLASSIFIED SECTION

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    AMERICAN SHAMAN HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77551-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77551-001-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    2NDC:77551-001-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    3NDC:77551-001-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    4NDC:77551-001-113785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2020
    Labeler - Cbd American Shaman, LLC (085803529)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cbd American Shaman, LLC085803529manufacture(77551-001)
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