COATS ALOE- allantoin jelly

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
• scrapes
• 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, animals 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 barbadenesis leaf juice, water, butylene glycol, carbomer, triethanolamine, xanthun gum, panthenol, glycerin, chlorphenesin, potassium sorbate, sodium benzoate, beta-glucan

Questions:

Toll free 888-650-0040

Package Label COATS ALOE GELLY 8 OZ

INGREDIENTS AND APPEARANCE

COATS ALOE 
allantoin jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70211-705
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
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHLORPHENESIN (UNII: I670DAL4SZ)

Product Characteristics
Color	yellow (CLEAR TO OFF YELLOW 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: 70211-705-08	237 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(70211-705)