THERAGESIC CREME- methyl salicylate cream 
Mainpointe Pharmaceuticals, LLC

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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THERA-GESIC ® Creme

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.

THERA-GESIC 3-oz

Theragesic carton

THERAGESIC CREME 
methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71269-005
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 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:71269-005-031 in 1 CARTON12/01/2018
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 - Mainpointe Pharmaceuticals, LLC (080544378)
Registrant - Mission Pharmacal Company (927726893)

Revised: 2/2020
Document Id: 9f55e38e-03bc-42fc-e053-2a95a90a1378
Set id: 9f55e38e-03bb-42fc-e053-2a95a90a1378
Version: 1
Effective Time: 20200220
 
Mainpointe Pharmaceuticals, LLC