Label: QYK BRANDS- ethyl 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 July 1, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses: • Hand Sanitizer to help decrease bacteria on the skin that could cause disease. • Recommended for repeated use.

  • WARNINGS

    Warnings For external use only, use on hands only.

    Flammable. Keep away from fire or flame.

    When using this product: • Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

    Stop use and ask doctor if • Irritation and redness develops. • Condition persists for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions • Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry. • For children under 6, use only under adult supervision. • Not recommended for infants.

  • STORAGE AND HANDLING

    Other information • Store below 110°F (43°C) • May discolor some fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredients Water, Glycerin, Aloe vera, Carbomer, Polyacrylate crosspolymer, Fragrance

  • SPL UNCLASSIFIED SECTION

    ALOE VERA REFRESHING GEL

    Kills More Than 99.99% of Germs and Bacteria

    Distributed By:

    QYK BRANDS, LLC.

    Garden Grove, CA 92843

    www.DrJsNatural.com

    Questions or Comments

    Please Call: 1-888-308-7078

  • Packaging

    IMAGEIMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    QYK BRANDS 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74416-171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74416-171-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    2NDC:74416-171-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    3NDC:74416-171-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    4NDC:74416-171-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    5NDC:74416-171-10300 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    6NDC:74416-171-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    7NDC:74416-171-351000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Guangzhou C-kang Biotechnology Co., Ltd. (415992294)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou C-kang Biotechnology Co., Ltd.415992294manufacture(74416-171)
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