COATS ALOE ANALGESIC- methyl salicylate lotion

COATS ALOE ANALGESIC by

Drug Labeling and Warnings

COATS ALOE ANALGESIC 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:

Methyl Salicylate 10%

Purpose:

Topical analgesic, topical pain relief for intact skin.

Warnings:

• For external use only.
• Avoid contact with eyes or mucous membranes.
• Do not apply to wounds or damaged skin with a heating pad.
• Discontinue if irritation develops.
• Wash hands with soap and water after use.
• Do not banadage tightly.

Stop use if:

Stop use and ask a doctor if condition worsens, if symptoms persist more than 7 days, or if symptoms worsen within a few days.

Pregnant or breastfeeding:

Not recommended if you are pregnant or breastfeeding.

Consult your physician.

Indications and Usage:

Temporary relief of minor aches and pains of muscles and joints associated with:

• arthritis
• simple backaches
• strains
• sprains
• bruises

Do not use:

Do not use in combination with other topical analgesic products.

Keep out of reach of children:

Keep out of reach of children.

If accidentally ingested, seek medical help or contact poison control immediately.

Directions:

Adults and children 12 years of age and older: Apply to affected areas no more than 3-4 times daily.

Children under 12 years of age: Consult a physician.

Other information:

Store between 15 o C and 30 o C (59 o F and 86 o F).

Inactive Ingredients:

aloe barbadenesis leaf juice, butylene glycol, caprylyl glycol, carbomer, cetearyl alcohol, cetyl alcohol, coconut oil, disodium EDTA, eucalyptus leaf oil, glyceryl stearate, isododecane, isopentylidiol, menthol, pentylene glycol, petrolatum, phenoxyethanol, potassium palmitol hydrolyzed wheat protein, apricot kernel oil, sodium hydroxide, water

Questions:

Toll free number 888-650-0040

Package Label COATS ALOE LINIMENT

INGREDIENTS AND APPEARANCE

COATS ALOE ANALGESIC 
methyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70211-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
COCONUT OIL (UNII: Q9L0O73W7L)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL (UNII: L7T10EIP3A)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: 70211-704-08	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/02/2015
2	NDC: 70211-704-33	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	part348	11/02/2015

Labeler - TYCHASIS CORPORATION (022731149)

Registrant - TYCHASIS CORPORATION (022731149)

Establishment
Name	Address	ID/FEI	Business Operations
BIOMED LABORATORIES		055329696	manufacture(70211-704)