Label: STAYKLEAR- alcohol liquid

  • NDC Code(s): 82140-432-01, 82140-432-02, 82140-432-03
  • Packager: eHealth Nexus LLC
  • 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 5, 2023

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  • Active Ingredient

    Ethyl Alcohol 63% by volume

  • Purpose

    Antiseptic

  • Uses

    Antiseptic rub and hand sanitizer to help reduce bacteria and viruses on skin that could cause disease. For use when soap and water are not available.

  • Warnings:

    Flammable. Keep away from fire and flame.

    For external use only. Do not ingest.

    When using this product, do not use in or near eyes.

    In case of contact, rinse eyes 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Wet hands thoroughly with product and rub hands together, palms, backs and nails and wrists, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

  • Other Information:

    Store below 110° F (43 C).

    •Dried product may turn brown from copper oxide.
    •May discolor certain fabrics or surfaces.

  • Inactive Ingredients:

    Water, glycerin, propylene glycol, sodium salicylate, panthenol,‡ salicylic acid, sodium lauryl sulfate, hydroxypropyl cellulose, niacinamide,** lactic acid, copper gluconate,* benzoic acid, adipic acid, acetic acid, glycine,* sodium chloride. **Vitamin B3, ‡Pro-vitamin B5

  • Package Label

    StayKlear Label 013.4 oz StayKlear 2023-04-05 2

  • INGREDIENTS AND APPEARANCE
    STAYKLEAR 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82140-432
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE 13576 (UNII: 5EM498GW35) 0.002 kg  in 1 kg
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.003 kg  in 1 kg
    LACTIC ACID (UNII: 33X04XA5AT) 0.0035 kg  in 1 kg
    WATER (UNII: 059QF0KO0R) 0.29 kg  in 1 kg
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) 0.0055 kg  in 1 kg
    PANTHENOL (UNII: WV9CM0O67Z) 0.008 kg  in 1 kg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.016 kg  in 1 kg
    SODIUM SALICYLATE (UNII: WIQ1H85SYP) 0.008 kg  in 1 kg
    GLYCERIN (UNII: PDC6A3C0OX) 0.036 kg  in 1 kg
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.006 kg  in 1 kg
    NIACINAMIDE (UNII: 25X51I8RD4) 0.0035 kg  in 1 kg
    ADIPIC ACID (UNII: 76A0JE0FKJ) 0.0015 kg  in 1 kg
    BENZOIC ACID (UNII: 8SKN0B0MIM) 0.002 kg  in 1 kg
    SALICYLIC ACID (UNII: O414PZ4LPZ) 0.006 kg  in 1 kg
    GLYCINE (UNII: TE7660XO1C) 0.001 kg  in 1 kg
    COPPER GLUCONATE (UNII: RV823G6G67) 0.0022 kg  in 1 kg
    ACETIC ACID (UNII: Q40Q9N063P) 0.0014 kg  in 1 kg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0006 kg  in 1 kg
    ORANGE OIL (UNII: AKN3KSD11B) 0.0015 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82140-432-010.213 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/03/2021
    2NDC:82140-432-020.053 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/16/2021
    3NDC:82140-432-030.09 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/16/2021
    Labeler - eHealth Nexus LLC (067923713)
    Registrant - eHealth Nexus LLC (067923713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrix117341868manufacture(82140-432)
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