PASMOL PAIN RELIEVING- menthol and methyl salicylate cream

Pasmol Pain Relieving by

Drug Labeling and Warnings

Pasmol Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Grafor, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Arthritis
• simple backache
• bruises
• sprains

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

• Adults and children three years of age and older: apply to affected area not more than 3-4 times daily.
• Children under 3 years of age: consult a doctor

Inactive ingredients

PETROLATUM

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

PASMOL PAIN RELIEVING 
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61361-820
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61361-820-03	85 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	04/08/2015

Labeler - Grafor, Inc. (135138811)

Establishment
Name	Address	ID/FEI	Business Operations
Grafor, Inc.		135138811	manufacture(61361-820)