COATS ALOE- lotions, oils, powders, and creams lotion 
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.

----------

COATS ALOE LOTION 85%

Active Ingredient

Allantoin 0.5%

Purpose

Skin protectant

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if:

Do not use on deep puncture wounds, animals bites, serious burns.

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.

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.

Directions

Apply as needed.

Inactive Ingredients

aloe barbadenesis leaf juice, ethylhexyl palmitate, glycerin, methyl gluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolamine, stearice acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

COATS ALOE LOTION 8 OZ

COATS ALOE LOTION 8 OZ

COATS ALOE 
lotions, oils, powders, and creams lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58826-702
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
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BOROGLYCERIN (UNII: U3LMU4AN21)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LAURETH-4 (UNII: 6HQ855798J)  
LAURETH-23 (UNII: N72LMW566G)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Colorwhite (white lotion, can be off-white due to natural variation of aloe vera) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58826-702-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/10/2015
2NDC:58826-702-33976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/10/2015
3NDC:58826-702-0259 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(58826-702)

Revised: 11/2015
Document Id: 241d866f-6820-58d4-e054-00144ff8d46c
Set id: 20d386db-0d51-172f-e054-00144ff88e88
Version: 4
Effective Time: 20151109
 
TYCHASIS CORPORATION