Label: COATS ALOE- allantoin lotion

  • Category: HUMAN OTC DRUG LABEL

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 November 9, 2015

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  • Active Ingredient

    Allantoin 0.5%

  • Purpose

    Skin protectant

  • Warnings

    For external use only.

    When using this product do not get into eyes.

  • STOP USE

    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
  • DO NOT USE

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

  • 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.

  • Keep out of reach of children

    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, ethylhexyl palmitate, glycerin, methyl gluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolamine, stearice acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

  • COATS ALOE LOTION 8 OZ

    COATS ALOE LOTION 8 OZ

  • INGREDIENTS AND APPEARANCE
    COATS ALOE 
    lotions, oils, powders, and creams lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58826-702
    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
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BOROGLYCERIN (UNII: U3LMU4AN21)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    C12-15 ALKYL 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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (white lotion, can be off-white due to natural variation of aloe vera) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58826-702-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/10/2015
    2NDC:58826-702-33976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/10/2015
    3NDC:58826-702-0259 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/10/2015
    Labeler - TYCHASIS CORPORATION (022731149)
    Registrant - TYCHASIS CORPORATION (022731149)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOMED LABORATORIES055329696manufacture(58826-702)
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