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.

When using this product do not get into eyes.

STOP USE

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

DO NOT USE

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

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.

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

INGREDIENTS AND APPEARANCE

COATS ALOE 
lotions, oils, powders, and creams lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58826-702
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
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
Color	white (white lotion, can be off-white due to natural variation of aloe vera)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58826-702-08	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/10/2015
2	NDC: 58826-702-33	976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/10/2015
3	NDC: 58826-702-02	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/10/2015

Labeler - TYCHASIS CORPORATION (022731149)

Registrant - TYCHASIS CORPORATION (022731149)

Establishment
Name	Address	ID/FEI	Business Operations
BIOMED LABORATORIES		055329696	manufacture(58826-702)