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%

Uses:

Skin protectant

Warnings

For external use only.

Do not get into eyes.

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, animal 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.

Directions:

Apply as needed.

Inactive Ingredients:

water, aloe barbadensis leaf juice, caprylic/-capric triglyceride, cetyl alcohol, postassium palmitoyl hydrolyzed wheat protein, glycerol stearate, pentylene glycol, butyrospermum parkii (shea) butter, c12-15 alkyl benzoate, glycerin, beta-glucan, sodium hyaluronate, glyceryl stearate SE, cetearath-20, dehydroacetic acid, benzyl alcohol

Questions:

Toll free number 888-650-0040

Package Label: COATS ALOE CREME 4 OZ

COATSALOECREME4OZ

COATS ALOE 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58826-703
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
WATER (UNII: 059QF0KO0R)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
POTASSIUM PALMITATE (UNII: KTC40CLC68)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SHEA BUTTER (UNII: K49155WL9Y)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
Colorwhite (thick white creme, can sometimes be off-white due to natural characteristics of aloe vera) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58826-703-04118 g in 1 JAR; Type 0: Not a Combination Product10/10/2015
2NDC:58826-703-16454 g in 1 JAR; 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(58826-703)

Revised: 10/2015
Document Id: 21b3c8ef-7748-0045-e054-00144ff8d46c
Set id: 20d1606d-fdb5-5ce8-e054-00144ff8d46c
Version: 2
Effective Time: 20151009
 
TYCHASIS CORPORATION