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Cool Heat by Dolgencorp Inc

Dosage form: cream
Ingredients: MENTHOL 10g in 100g, METHYL SALICYLATE 30g in 100g
Labeler: Dolgencorp Inc
NDC Code: 55910-405

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.

Cool Heat

Active ingredients

Menthol                 10%

Methyl salicylate    30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

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 use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

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

Keep out of reach of children.

If 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 not more than 4 times daily

Children 12 years or younger: ask a doctor

Inactive ingredients

carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water.

PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH
COOL HEAT PAIN RELIEVING CREAM
NET WT 1.25 OZ (35 g)

COOL HEAT 
menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-405
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE 
CETYL ESTERS WAX 
OLETH-3 PHOSPHATE 
STEARIC ACID 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:55910-405-3535 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/29/2016
Labeler - Dolgencorp Inc (068331990)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-405)

Revised: 07/2016
 
Dolgencorp Inc

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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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