Label: EGOLAN- 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 August 6, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    ■ To decrease bacteria on the skin that could cause disease. ■ When water, soap, and towel are not available. ■ Recommended for repeated use.

  • Warnings

    For external use only: hands.

    Flammable. Keep away from fire or flame.

    When using this product ■ Keep out of eyes, ears, or mouth. ■ In case of eye contact, flush eyes thoroughly with water. ■ Avoid contact with broken skin. ■ Do not inhale or ingest.

    Stop use and ask a doctor if ■ redness or irritation develop ■ condition persists for more than 72 hours

    Keep out of reach of children. ■ Children should be supervised by an adult when using this product. ■ If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions ■ Wet hands thoroughly with product and allow to dry without wiping. ■ No rinsing required. ■ For children under 6, use only under adult supervision. ■ Not recommended for infants.

  • STORAGE AND HANDLING

    Other information ■ Store below 105°F (40°C). ■ May discolor certain fabrics. ■ Harmful to wood finishes & plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Triethanolamine, Carbomer, Aloe Barbadensis (Aloe Vera) Gel, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E).

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    ADVANCED MOISTURIZING FORMULA WITH ALOE AND VITAMIN E

    Manufacturer: Sanrace Biotechnology Co., Ltd.

    Address: 268 Yanzhou Road, Lanxi Economic Development zone, Zhejiang Province.

    Made in China

  • Packaging

    IMAGE1IMAGE2IMAGE3

  • INGREDIENTS AND APPEARANCE
    EGOLAN 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75448-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75448-027-2360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    2NDC:75448-027-222 in 1 BLISTER PACK08/01/2020
    2NDC:75448-027-2360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:75448-027-21237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - Sanrace Biotechnology Co., Ltd. (543000938)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanrace Biotechnology Co., Ltd.543000938manufacture(75448-027)
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