Skip to Content

← See all Theragesic Creme brands

Theragesic Creme by Proficient Rx LP

Medically reviewed on April 30, 2018

Dosage form: gel
Ingredients: METHYL SALICYLATE 150mg in 1g, MENTHOL 10mg in 1g
Labeler: Proficient Rx LP
NDC Code: 63187-078

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.

Drug Facts

Active Ingredients

Purpose

Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic

Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant

Use

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

arthritis
simple backaches
strains
bruises
sprains

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

immediately shower or bath
if skin is sensitive to oil of wintergreen (methyl salicylate)
on wounds or damaged skin

Ask a doctor before use

for children under 2 and to 12 years of age
if prone or sensitive to allergic reaction from aspirin or salicylate

When using this product

discontinue use if skin irritation develops, or redness is present
do not swallow
do not use a heating pad after application of THERA-GESIC®

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.

Dosage and Administration

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

Repackaged by:

Proficient Rx LP

Westlake Village, CA 91362

THERAGESIC CREME 
methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-078(NDC:0178-0320)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE150 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
DIMETHICONE 
GLYCERIN 
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
TROLAMINE 
METHYLPARABEN 
SODIUM LAURYL SULFATE 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:63187-078-851 TUBE in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/1981
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022RELABEL(63187-078), REPACK(63187-078)

 
Proficient Rx LP

← See all Theragesic Creme brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide