COATS ALOE- allantoin cream

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 and ask doctor 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.

Indications and Usage:

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, animal bites, serious burns.

Keep out of reach of children:

If swallowed, get medical help or contact a poison control right away.

Directions:

Apply as needed.

Inactive Ingredients:

water, aloe barbadenesis leaf juice, caprylic/capric triglyceride, cetyl alcohol, potassium palmityl hydrolyzed wheat protein, glyceryl stearate, pentylene glycol, butryospermum parkii (shea) butter, C12-15 alkyl benzoate, glycerin, beta-glucan, sodium hyaluronate, glyceryl stearate SE, ceteareth-20, dehydroacetic acid, benzyl alcohol

Questions:

Toll free number 888-650-0040

Package Label COATS ALOE CREME

INGREDIENTS AND APPEARANCE

COATS ALOE 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70211-703
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SHEA BUTTER (UNII: K49155WL9Y)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM PALMITATE (UNII: KTC40CLC68)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Product Characteristics
Color	white (can be 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: 70211-703-04	118 g in 1 JAR; Type 0: Not a Combination Product	11/02/2015
2	NDC: 70211-703-16	454 g in 1 JAR; 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(70211-703)