Label: SERENE CLEAN AND PURE HAND SANITIZER GEL- ethanol 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 January 1, 2021

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  • Active ingredient

    Ethyl Alcohol 65% v/v.

  • Purpose

    Antiseptic

  • Use

    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

    Water, glycerin, carbomer, aloe

  • Package Label - Principal Display Panel

    Serene Clean & Pure

    Be Wise & Sanitize

    Gel Hand Sanitizer

    www.serenepure.com

    (424) 329-2515

    ABOUT

    Serene Clean & Pure is a family owned company that believes in honest and helpful products.

    Serene Clean & Pure is a quickly drying hand sanitizer that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life

    Manufactured by:

    CALIFORNIA CHEMICAL

    (424) 292-3424

    Costa Mesa, CA 92626

    www.calichemical.com

    Front label

  • INGREDIENTS AND APPEARANCE
    SERENE CLEAN AND PURE HAND SANITIZER GEL 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78643-300
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78643-300-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/05/2020
    Labeler - Serene Clean & Pure LLC (117539963)
    Registrant - Serene Clean & Pure LLC (117539963)
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