Label: COATS ALOE- allantoin jelly

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2024

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  • Active Ingredient:

    Allantoin 0.5%

  • Purpose:

    Skin Protectant

  • Warnings:

    For external use only.

    Do not get into eyes.

  • Stop use if:

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days, or clear up and occur again within a few days.

  • Uses:

    Temporarily protects minor:

    • cuts
    • scrapes
    • burns

    Helps prevent and temporarily protects and helps relieve chaffed, chapped or cracked skin.

    Helps prevent and protect from the drying effects of wind and cold weather.

  • Caution:

    Do not use on deep puncture wounds, animals bites, serious burns.

  • Keep out of reach of children:

    If swallowed, get medical help or contact a poison control center right away.

  • Directions:

    Apply as needed.

  • Inactive Ingredients:

    aloe barbadenesis leaf juice, water, butylene glycol, carbomer, triethanolamine, xanthun gum, panthenol, glycerin, chlorphenesin, potassium sorbate, sodium benzoate, beta-glucan

  • Questions:

    Toll free 888-650-0040

  • Package Label COATS ALOE GELLY 8 OZ

    COATS ALOE GELLY 8 OZ

  • INGREDIENTS AND APPEARANCE
    COATS ALOE 
    allantoin jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-705
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Product Characteristics
    Coloryellow (CLEAR TO OFF YELLOW DUE TO NATURAL VARIATIONS OF ALOE VERA) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70211-705-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/02/2015
    Labeler - TYCHASIS CORPORATION (022731149)
    Registrant - TYCHASIS CORPORATION (022731149)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOMED LABORATORIES055329696manufacture(70211-705)
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