Label: THERAWORX PROTECT ADVANCED HYGIENE WITH SKIN PROTECTANT ALLANTOIN 4 COUNT WIPE- allantoin cloth

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 23, 2024

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  • Drug Facts

  • Active Ingredient

    Allantoin 0.65%

    Purpose

    Skin Protectant

  • Uses

    •  temporarily protects minor:
    • cuts 
    • scrapes
    • burns
    • temporarily protects chapped or cracked skin
  • Warnings

    For external use only

    Do not use

    • on puncture wounds
    • on animal bites
    • on serious burns

    When using this product

    • do not get into eyes

    Stop use and ask  a doctor if:

    • condition worsens 
    • symptoms last more then 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children

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

  • Directions

    • apply as needed
  • Other Information

    • store between 32 F and 120 F
    • do not use if seal is broken
  • Inactive Ingredients

    (Alphabetical) Aloe barbadensis Leaf Extract, Aloe barbadensis Leaf juice, Aqua (water), Citrus Grandis (Grapefruit) seed Extract, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Methylparaben, Parfum (Fragrance) PEG/PPG-4/12 Dimethicone, Propylparaben, Tetrasodium EDTA,Tocopheryl Acetate (Vitamin E), Yeast Extract

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    THERAWORX PROTECT ADVANCED HYGIENE WITH SKIN PROTECTANT ALLANTOIN 4 COUNT WIPE 
    allantoin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN6.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SILVER (UNII: 3M4G523W1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-040-004 in 1 CARTON07/01/2024
    118 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/01/2024
    Labeler - AVADIM HOLDINGS, INC. (118512488)
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