The following Structured Product Label (SPL) was submitted to the FDA by Mainpointe Pharmaceuticals, Llc for the product Theragesic Creme (NDC 71269-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
if skin is sensitive to oil of wintergreen (methyl salicylate)
immediately shower or bath
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.
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
Carbomer 934, dimethicone, glycerine, methylparaben, propylparaben, sodium laurel sulfate, trolamine, water
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. MainPointe Pharmaceuticals, LLC Louisville, KY 40202 Rev 50563R1218
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.
* Please review the disclaimer below.
