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 90%

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

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 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 on deep puncture wounds, animal bits, serious burns.

COATS ALOE GELLY 8 OZ

COATS ALOE GELLY 8 OZ

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)

Revised: 10/2015
Document Id: 21b3c8ef-774a-0045-e054-00144ff8d46c
Set id: 20d47c70-36a2-0723-e054-00144ff8d46c
Version: 2
Effective Time: 20151009
 
TYCHASIS CORPORATION