CARE ONE COOL HEAT PAIN RELIEVING

Dosage form: cream
Ingredients: MENTHOL 10g in 100g, METHYL SALICYLATE 30g in 100g
Labeler: AMERICAN SALES COMPANY
NDC Code: 41520-863

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.

Drug Facts

Active ingredients                                                                                     Purpose

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

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

Uses

temporarily relieves minor pain associated with

  • Arthritis
  • Simple backache
  • Muscle strains
  • Sprains
  • Bruises
  • Cramps

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

  • Use only as directed
  • Do not bandage tightly or sue with a heating pad
  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds, damaged, broken or irritated skin

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

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

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary but no more than 4 times daily
  • close cap tightly after use
  • keep carton as it contains important information
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

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CARE ONE COOL HEAT PAIN RELIEVING 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-863
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX 
OLETH-3 PHOSPHATE 
STEARIC ACID 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:41520-863-351 TUBE (TUBE) 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: 03/2012
 
AMERICAN SALES COMPANY

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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