Label: DEVOLVER PREMIUM TISSUE- alcohol liquid

  • 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 30, 2020

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  • Active ingredient

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

    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

    Water, Glycerin, Hydroxy Acetophenone, Cetylpyridinium Chloride, Citric Acid, Butylene Glycol, Aloe ferox leaf extract, Fragrance (Lime)

  • Package Label

    100g NDC: 75001-204-01 Label 1

    100g NDC: 75001-204-01 Label 2

    100g NDC: 75001-204-02 Label 1

    100g NDC: 75001-204-02 Label 2

    100g NDC: 75001-204-03 Label 1

    100g NDC: 75001-204-03 Label 2

    100g NDC: 75001-204-04 Label 1

    100g NDC: 75001-204-04 Label 2

    335g NDC: 75001-204-05 Label 1

    335g NDC: 75001-204-05 Label 2

    335g NDC: 75001-204-06 Label 1

    335g NDC: 75001-204-06 Label 2

    100g NDC: 75001-204-07 Label

    300g NDC: 75001-204-08 Label

    400g NDC: 75001-204-09 Label

    500g NDC: 75001-204-10 Label

    800g NDC: 75001-204-11 Label

    1100g NDC: 75001-204-12 Label

  • INGREDIENTS AND APPEARANCE
    DEVOLVER PREMIUM TISSUE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75001-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE FEROX LEAF (UNII: 0D145J8EME)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75001-204-01100 g in 1 POUCH; Type 0: Not a Combination Product05/17/2020
    2NDC:75001-204-02100 g in 1 POUCH; Type 0: Not a Combination Product05/17/2020
    3NDC:75001-204-03100 g in 1 POUCH; Type 0: Not a Combination Product05/23/2020
    4NDC:75001-204-04100 g in 1 POUCH; Type 0: Not a Combination Product05/23/2020
    5NDC:75001-204-05335 g in 1 POUCH; Type 0: Not a Combination Product06/08/2020
    6NDC:75001-204-06335 g in 1 POUCH; Type 0: Not a Combination Product06/08/2020
    7NDC:75001-204-07100 g in 1 POUCH; Type 0: Not a Combination Product06/21/2020
    8NDC:75001-204-08300 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    9NDC:75001-204-09400 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    10NDC:75001-204-10500 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    11NDC:75001-204-11800 g in 1 BOTTLE; Type 0: Not a Combination Product05/17/2020
    12NDC:75001-204-121100 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/17/2020
    Labeler - Devolver Cosmetics Co., Ltd (695733244)
    Registrant - Devolver Cosmetics Co., Ltd (695733244)
    Establishment
    NameAddressID/FEIBusiness Operations
    Devolver Cosmetics Co., Ltd695733244manufacture(75001-204)
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