COATS ALOE- allantoin cream 
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 CREME

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:

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

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)

Revised: 1/2023
Document Id: f18f1137-4bda-6155-e053-2995a90a688f
Set id: 2390d20f-58c4-084e-e054-00144ff88e88
Version: 3
Effective Time: 20230105
 
TYCHASIS CORPORATION