COATS ALOE ANALGESIC- methyl salicylate lotion 
TYCHASIS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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COATS ALOE LINIMENT TOPICAL ANALGESIC

Active Ingredient:

Methyl Salicylate 10%

Purpose:

Topical analgesic, topical pain relief for intact skin.

Warnings:

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:

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

COATS ALOE LINIMENT 8 OZ

COATS ALOE ANALGESIC 
methyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (can be off white due to natural variations of aloe vera) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70211-704-08237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
2NDC:70211-704-33976 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01711/02/2015
Labeler - TYCHASIS CORPORATION (022731149)
Registrant - TYCHASIS CORPORATION (022731149)
Establishment
NameAddressID/FEIBusiness Operations
BIOMED LABORATORIES055329696manufacture(70211-704)

Revised: 5/2023
Document Id: fb362ebb-d8ea-4617-e053-6394a90a7f9d
Set id: 2392751d-4025-3a1d-e054-00144ff88e88
Version: 6
Effective Time: 20230508
 
TYCHASIS CORPORATION