Label: COATS ALOE- allantoin lotion

  • NDC Code(s): 70211-702-02, 70211-702-08, 70211-702-33
  • Packager: TYCHASIS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2024

If you are a consumer or patient please visit this version.

  • 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
    • scapes
    • 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, animal 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 barbanesis leaf juice, ethylhexyl palmitate, glycerin, methylgluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolomine, stearic acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

  • Questions:

    Toll free 888-650-0040

  • Package label COATS ALOE LOTION

    COATS ALOE LOTION 8 OZ

  • INGREDIENTS AND APPEARANCE
    COATS ALOE 
    allantoin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-702
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-23 (UNII: N72LMW566G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BOROGLYCERIN (UNII: U3LMU4AN21)  
    Product Characteristics
    Colorwhite (may be slightly off white due to natural variations of aloe vera) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70211-702-0259 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
    2NDC:70211-702-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
    3NDC:70211-702-33976 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(70211-702)