Label: COATS ALOE- allantoin cream

  • NDC Code(s): 70211-703-04, 70211-703-16
  • 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 and ask doctor 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.

  • Indications and Usage:

    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, animal bites, serious burns.

  • Keep out of reach of children:

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

  • Directions:

    Apply as needed.

  • Inactive Ingredients:

    water, aloe barbadenesis leaf juice, caprylic/capric triglyceride, cetyl alcohol, potassium palmityl hydrolyzed wheat protein, glyceryl stearate, pentylene glycol, butryospermum parkii (shea) butter, C12-15 alkyl benzoate, glycerin, beta-glucan, sodium hyaluronate, glyceryl stearate SE, ceteareth-20, dehydroacetic acid, benzyl alcohol

  • Questions:

    Toll free number 888-650-0040

  • Package Label COATS ALOE CREME

    COATS ALOE CREME 4 OZ

  • INGREDIENTS AND APPEARANCE
    COATS ALOE 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-703
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM PALMITATE (UNII: KTC40CLC68)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Product Characteristics
    Colorwhite (can be off-white due to natural variations of aloe vera) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70211-703-04118 g in 1 JAR; Type 0: Not a Combination Product11/02/2015
    2NDC:70211-703-16454 g in 1 JAR; 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(70211-703)
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