Label: COATS ALOE- allantoin jelly

  • 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 October 9, 2015

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

View All Sections
  • Active Ingredient

    Allantoin 0.5%

  • Purpose

    Skin protectant.

  • Warnings

    For external use only.

    When using this product do not get into eyes.

  • 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.

  • 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.

  • Inactive ingredients

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

  • Directions

    Apply as needed

  • Use

    Apply as needed

  • 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.

  • DO NOT USE

    Do not use on deep puncture wounds, animal bits, serious burns.

  • 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:58826-705
    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
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Product Characteristics
    Coloryellow (CLEAR TO YELLOW, COLOR CAN VARY DUE TO NATURAL VARIATIONS OF ALOE VERA) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58826-705-08237 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(58826-705)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!