MENTHOL AND METHYL SALICYLATE  - menthol and methyl salicylate stick 
H.J. Harkins Company, 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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Menthol and Methyl Salicylate

PAIN RELIEVING STICK
Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

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

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive ingredients

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale
Nipomo, CA 93444

MM1

MENTHOL AND METHYL SALICYLATE  
menthol and methyl salicylate stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-028(NDC:41167-0089)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 30 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CERESIN (UNII: Q1LS2UJO3A)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52959-028-03 49 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 06/01/1991
Labeler - H.J. Harkins Company, Inc. (147681894)
Establishment
Name Address ID/FEI Business Operations
Chattem Plant 1 003336013 MANUFACTURE
Establishment
Name Address ID/FEI Business Operations
Chattem Plant 2 830410721 MANUFACTURE

Revised: 3/2012
Document Id: 400e1d37-ae36-4c98-95fb-59732443853c
Set id: 5488358e-2c90-433d-a850-7dcb31ca82d2
Version: 5
Effective Time: 20120301
 
H.J. Harkins Company, Inc.