COATS ALOE ANALGESIC- methyl salicylate, aloe 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

ACTIVE INGREDIENT

METHYL SALICYLATE 10% TOPICAL ANALGESIC

MENTHOL 1%

USE

TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH: ARTHRITIS, SIMPLE BACKACHES, STRAINS, SPRAINS, BRUISES

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

DO NOT USE IN COMBINATION WITH OTHER ANALGESIC PRODUCTS

WASH HANDS WITH SOAP AND WATER AFTER USE

DO NOT BANDAGE TIGHTLY

STOP USE AND ASK DOCTOR IF CONDITION WORSENS IF SYMPTOMS PERSIST MORE THAN 7 DAYS, OR IF SYMPTOMS WORSEN WITHIN A FEW DAYS.

NOT RECOMMENDED IF YOU ARE PREGNANT OR BREASTFEEDING. CONSULT YOUR PHYSICIAN.

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 0C AND 30 0C (59 0F AND 86 0F)

INACTIVE INGREDIENTS

Aloe Barbadenesis Leaf Juice, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Disodium EDTA, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Isododecane, Isopentylidiol, Menthol, Pentylene Glycol, Petrolatum, Phenoxyethanol, Potassium palmitol hyrdrolyzed wheat protein, Prunus Armeniaca (Apricot Kernel Oil), Sodium Hyrdroxide, Water (Aqua)

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If accidentally ingested seek medical help or contact Poison Control immediately.

PACKAGE LABEL COATS ALOE LINIMENT 8 OZ

COATS ALOE LINIMENT 8 OZ PACKAGE LABEL

QUESTIONS

888-650-0040

customerservice@coatsaloevera.com

COATS ALOE ANALGESIC 
methyl salicylate, aloe lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58826-704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
ISODODECANE (UNII: A8289P68Y2)  
ISOPENTYLDIOL (UNII: 19NOL5474Q)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MENTHOL (UNII: L7T10EIP3A)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58826-704-08237 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/29/2015
2NDC:58826-704-33976 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/29/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/29/2015
Labeler - TYCHASIS CORPORATION (022731149)

Revised: 10/2015
Document Id: 215cfa24-8947-0e66-e054-00144ff8d46c
Set id: 135157a2-cd0d-61a8-e054-00144ff8d46c
Version: 3
Effective Time: 20151005
 
TYCHASIS CORPORATION