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
  • Marketing Status: OTC monograph 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 January 5, 2023

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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
    • 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 finalpart34711/02/2015
    Labeler - TYCHASIS CORPORATION (022731149)
    Registrant - TYCHASIS CORPORATION (022731149)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOMED LABORATORIES055329696manufacture(70211-702)
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