CARE ONE COOL HEAT PAIN RELIEVING - menthol, methyl salicylate cream 
AMERICAN SALES COMPANY

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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Drug Facts

Active ingredients                                                                                     Purpose

Menthol 10%............................................................................................Topical Analgesic

Methyl Salicylate 30%...............................................................................Topical Analgesic

Uses

temporarily relieves minor pain associated with

Warning

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions Adults and children over 12 years

Children 12 years or younger: Ask a doctor

Inactive ingredients

Carbomer, Cetyl Esters, Emulsifying Wax, Oleth-3 phosphate, Stearic Acid, Triethanolamine, Water

DISTRIBUTED BY: AMERICAN SALES COMPANY

4201 WALDEN AVENUE, LANCASTER, NY 14086

www.care1.info

Made in Korea

image of carton labelEnter section text here

CARE ONE COOL HEAT PAIN RELIEVING 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-863
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-863-351 in 1 CARTON
135 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2012
Labeler - AMERICAN SALES COMPANY (809183973)

Revised: 3/2012
Document Id: 9c1c705f-deab-4b86-8671-0e50174bd027
Set id: a1023c14-88c4-4f00-9db5-617b6acf7245
Version: 1
Effective Time: 20120301
 
AMERICAN SALES COMPANY