Label: PRIMA CLEAN HANDS MOISTURIZING HAND SANITIZERSPRAY- ethyl alcohol spray

  • 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 April 13, 2022

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  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • Helps reduce bacteria on the skin
    • Recommended for repeated use
  • Warnings

    • For external use only
    • Flammable, keep away from fire, sparks, and sources of ignition.
      • When using this product:
      • Keep out of eyes
      • In case of contact with eyes, flush thoroughly with water
      • Avoid contact with broken skin
      • Stop use and ask doctor if irritation and redness develop and persist for more than 72 hours.

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

  • Directions

    • Spray directly on all surfaces on hands and rub until dry
    • For children under 6, use adult supervision
    • Not recommended for infants
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice

    Cannabis Sativa (Hemp) Flower/Leaf/Stem Extract

    Ceramide NG

    Chenopodium Quinoa Seed Extract

    Citrullus Lanatus (Watermelon) Fruit Extract

    Eucalyptus Globulus Leaf Oil

    Glycerin

    Lavandula Angustifolia (Lavender) Oil

    Mentha Piperita (Peppermint) Oil

    Olea Europaea (Olive) Fruit Oil

    Ricinus Communis (Castor) Seed Oil

    Sodium Lactate

    Sodium PCA

    Sucrose

    Urea

    Water

  • Other

    Do not store above 104°/ 40°C

  • PRINCIPAL DISPLAY PANEL

    Made in the United States with thoughtfully sourced global materials

    Formulated, Quality Tested and Distributed by The Uplifters' Prima, PBC (a Public Benefit Corp.)

    Sanata Monica, CA 90401 | Prima Support: prima.co.hi

    Adverse Health Events: 855-774-6226

    prima.co © 2020 The Uplifters' Prima, 1PBC

  • INGREDIENTS AND APPEARANCE
    PRIMA CLEAN HANDS MOISTURIZING HAND SANITIZERSPRAY 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-355
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CERAMIDE NG (UNII: C04977SRJ5)  
    WATERMELON (UNII: 231473QB6R)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    HEMP (UNII: TD1MUT01Q7)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76150-355-7660 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/01/2021
    Labeler - Bell International Laboratories, Inc (967781555)
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