PASMOL PAIN RELIEVING- menthol and methyl salicylate cream 
Grafor, Inc.

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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Pasmol Pain Relieving Ointment

Active ingredients

Menthol 5%

Methyl Salicylate 14%

Purpose

Pain Relieving

Uses

For the temporary relief of minor aches and pains of the muscles and joints associated with:

Warnings

For external use only.

Do not use

  • in the eyes
  • on mucous membranes
  • on wounds or damaged skin

When using this product

  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few day

  • redness is present

  • excessive irritation of the skin develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

PETROLATUM

MANUFACTURED BY GRAFOR INC. 1360 CASTELLANAS ST LA RAMBLA PONCE, PR 00730 UNITED STATES (787) 842-1423 WWW.PASMOL.COM REPORT ADVERSE EVENTS TO GRAFOR INC.

Pasmol Pain Relieving Ointment, 85g (61361-820-03)

PASMOL

“Arthritis Formula”

“Formula Artritis”

Pain Relieving Ointment

Net Wt./ Peso Neto 3 oz (85 g)

Label

PASMOL PAIN RELIEVING 
menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61361-820
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61361-820-0385 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34804/08/2015
Labeler - Grafor, Inc. (135138811)
Establishment
NameAddressID/FEIBusiness Operations
Grafor, Inc.135138811manufacture(61361-820)

Revised: 4/2015
Document Id: d1e271c3-82f1-4030-84bb-4dadf26c1097
Set id: a51221f7-4539-4034-b709-7c47a344bce1
Version: 2
Effective Time: 20150408
 
Grafor, Inc.