Label: PASMOL PAIN RELIEVING- menthol and methyl salicylate cream
- NDC Code(s): 61361-820-03
- Packager: Grafor, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated April 8, 2015
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- Active ingredients
Methyl Salicylate 14%Close
For the temporary relief of minor aches and pains of the muscles and joints associated with:
- simple backache
For external use only.
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.
- 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
- 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.Close
- Pasmol Pain Relieving Ointment, 85g (61361-820-03)
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)