THERAGESIC CREME- methyl salicylate gel 
A-S Medication Solutions

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.

----------

THERA-GESIC ® Creme

Drug Facts

Active IngredientsPurpose
Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic
Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant

Use

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

Warnings

For external use only. Use only as directed. Avoid contact with eyes or mucous membranes.

Do not bandage, wrap, cover, use a heating pad after, or recline upon skin treated with THERA-GESIC ®.

Do not use

Ask a doctor before use

When using this product

Stop use and ask a doctor if condition worsens, or if 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 professional before use.

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 or more years of age. Apply thin layers of crème into and around the sore or painful area, not more than 3 to 4 times daily. The number of thin layers controls the intensity of the action of THERA-GESIC ®. One this layer provides a mild effect, two thin layers provide a strong effect and three thin layers provide a very strong effect. SEE WARNINGS. Wash hands thoroughly after application.

Other information

Showering or washing the area after application of THERA-GESIC ® will leave the area fragrance-free without diminishing the therapeutic effect. Avoid contact with clothing or other surfaces. Store at 20-25°C (68-77°F).

Inactive ingredients

Questions (210) 696-8400 (M-Th 8:00-5:30 CST)

SHARE BEFORE USE: IT IS NORMAL FOR THIS PRODUCT TO GIVE THE IMPRESSION OF A LIQUID SOUND UON SHAKING. DO NOT ALLOW THERA-GESIC ® TO COMEIN CONTACT WITH ANY SURFACE, OTHER THAN SKIN.

Do not use this product if tube is punctured. Lot number and expiration date on end of carton.

MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355

50588 03 Rev 001090




THERA-GESIC 5-oz

Product: 50090-0430

NDC: 50090-0430-0 85 g in a TUBE / 1 in a CARTON

METHYL SALICYLATE

Label Image
THERAGESIC CREME 
methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0430(NDC:0178-0320)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-0430-01 in 1 CARTON11/28/2014
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/1981
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0430)

Revised: 4/2021
Document Id: 1e418d6b-0ec2-407d-87bc-2a91ccb5ff50
Set id: af2542d2-e609-4c25-8f12-6ce00836543c
Version: 13
Effective Time: 20210414
 
A-S Medication Solutions