COATS ALOE- allantoin jelly 
TYCHASIS CORPORATION

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.

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COATS ALOE GELLY

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:

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, animals 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 barbadenesis leaf juice, water, butylene glycol, carbomer, triethanolamine, xanthun gum, panthenol, glycerin, chlorphenesin, potassium sorbate, sodium benzoate, beta-glucan

Questions:

Toll free 888-650-0040

Package Label COATS ALOE GELLY 8 OZ

COATS ALOE GELLY 8 OZ

COATS ALOE 
allantoin jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-705
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
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Product Characteristics
Coloryellow (CLEAR TO OFF YELLOW DUE TO NATURAL VARIATIONS OF ALOE VERA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70211-705-08237 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(70211-705)

Revised: 1/2023
Document Id: f18f3ef4-76c0-33a5-e053-2995a90aeba4
Set id: 2393ef7e-c7da-07b4-e054-00144ff88e88
Version: 3
Effective Time: 20230105
 
TYCHASIS CORPORATION