COATS ALOE- allantoin lotion

COATS ALOE by

Drug Labeling and Warnings

COATS ALOE by is a Otc medication manufactured, distributed, or labeled by TYCHASIS CORPORATION, BIOMED LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• cuts
• scapes
• burns

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.

Inactive Ingredients:

aloe barbanesis leaf juice, ethylhexyl palmitate, glycerin, methylgluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolomine, stearic acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

Questions:

Toll free 888-650-0040

Package label COATS ALOE LOTION

INGREDIENTS AND APPEARANCE

COATS ALOE 
allantoin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70211-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALKYL (C12-15) 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)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
BOROGLYCERIN (UNII: U3LMU4AN21)

Product Characteristics
Color	white (may be slightly off white due to natural variations of aloe vera)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70211-702-02	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/02/2015
2	NDC: 70211-702-08	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/02/2015
3	NDC: 70211-702-33	976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/02/2015

Labeler - TYCHASIS CORPORATION (022731149)

Registrant - TYCHASIS CORPORATION (022731149)

Establishment
Name	Address	ID/FEI	Business Operations
BIOMED LABORATORIES		055329696	manufacture(70211-702)