THERAGESIC PLUS- methyl salicylate gel 
Mission Pharmacal Company

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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Theragesic Plus

Drug Facts

Active IngredientsPurpose
Methyl Salicylate 25%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant
Menthol 4%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic

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 ® PLUS.

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 ® PLUS. 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 ® PLUS 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

Aloe Vera, Carbomer Homopolymer Type C, Dimethicone, Glycerine, Methylparaben, Propylparaben, Sodium Lauryl Sulfate, Trolamine, Water.

To Report a serious adverse event or obtain product information, call (210) 696-8400

SHARE BEFORE USE: IT IS NORMAL FOR THIS PRODUCT TO GIVE THE IMPRESSION OF A LIQUID SOUND UON SHAKING. DO NOT ALLOW THERA-GESIC ® PLUS TO COME IN 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

50564 C03 Rev 001110




THERA-GESIC ® PLUS Carton
NDC: 0178-0350-03

theragesic-plus-carton
theragesic-plus-carton--0178-0350-03
THERAGESIC PLUS 
methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (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:0178-0350-031 in 1 CARTON01/01/1981
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 - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893manufacture(0178-0350)

Revised: 8/2019
Document Id: 90156099-9aac-9bd8-e053-2a95a90abca0
Set id: 6e7bccc8-1823-4b45-d047-f0979a8e0443
Version: 4
Effective Time: 20190814
 
Mission Pharmacal Company