Label: DEVOLVER PREMIUM GEL- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 2, 2020

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  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • Do not use

    in children less than 2 months of age

    on open skin wounds

  • When using this product

    keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    if irritation or rash occurs.

    These may be signs of a serious condition.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

    For children under 6, use only under adult supervision.

  • Other information

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    Purified Water, Glycerin, Carbomer, Fragrance, Trolamine, Aleo Extract(09), Parsley Extract

  • Package Label

    60ml NDC: 75001-201-01 Label

    100ml NDC: 75001-201-02 Label

    236ml NDC: 75001-201-03 Label

    500ml NDC: 75001-201-04 Label

    3785ml NDC: 75001-201-05 Label

    120ml NDC: 75001-201-06 Label

    350ml NDC: 75001-201-07 Label

    300ml NDC: 75001-201-08 Label

  • INGREDIENTS AND APPEARANCE
    DEVOLVER PREMIUM GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75001-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.00075 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75001-201-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
    2NDC:75001-201-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
    3NDC:75001-201-03236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/08/2020
    4NDC:75001-201-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/08/2020
    5NDC:75001-201-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
    6NDC:75001-201-06120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    7NDC:75001-201-07350 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    8NDC:75001-201-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/08/2020
    Labeler - Devolver Cosmetics Co., Ltd (695733244)
    Registrant - Devolver Cosmetics Co., Ltd (695733244)
    Establishment
    NameAddressID/FEIBusiness Operations
    Devolver Cosmetics Co., Ltd695733244manufacture(75001-201)
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