Label: PREMIER PURE PROTECTION- 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 20, 2020

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  • Active Ingredient

    Ethyl Alcohol 72% v/v.

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

    When using this product do not use in or near the eyes.In case of contact rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using PREMIER PURE.
  • Other information

    • Store below 110º F (43º C).
    • May discolor certain fabrics or surfaces.
    • This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.
  • Inactive ingredients

    Water, Acrylates Copolymer, Glycerin, Hydrolyzed Jojoba Esters, Aminomethyl Propanol, Fragrance

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    PREMIER PURE PROTECTION 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73945-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73945-005-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    2NDC:73945-005-0289 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    3NDC:73945-005-03236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    4NDC:73945-005-04946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    5NDC:73945-005-051893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    6NDC:73945-005-063785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2020
    Labeler - RPP Products, Inc. (623623852)
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