FDA.reportPublic FDA data

Theragesic Creme

Manufacturer
Mission Pharmacal Company
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:26:38

Label at a glance#

ProductTheragesic
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

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

OTC - PURPOSE SECTION

Use

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

  • arthritis
  • simple backaches
  • strains
  • bruises
  • sprains

WARNINGS SECTION

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 ®.

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

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 ®

OTC - STOP USE SECTION

Stop use and ask a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE FORMS & STRENGTHS SECTION

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.

INDICATIONS & USAGE SECTION

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 INGREDIENT SECTION

Inactive ingredients

OTC - QUESTIONS SECTION

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

PRECAUTIONS SECTION

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 3-oz

HOW SUPPLIED SECTION

LabelLabel

THERA-GESIC 3-oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THERA-GESIC 3-ozTHERA-GESIC 3-oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259203menthol 1 % / methyl salicylate 15 % Topical CreamPSN7
724160THERA-GESIC Pain Relieving Creme 1 % / 15 % Topical CreamPSN7
724160menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical Cream [Thera-Gesic]SBD7
259203menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD7
259203menthol 1 % / methyl salicylate 15 % Topical CreamSY7
724160Thera-Gesic (menthol 10 MG/ML / methyl salicylate 150 MG/ML) Topical CreamSY7
724160Thera-Gesic Pain Relieving Creme (menthol 1 % / methyl salicylate 15 % ) Topical CreamSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0320-032023-08-31C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-052023-08-31C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-162023-08-31C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-032022-01-28C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-052022-01-28C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-162022-01-28C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0320-03Theragesic85 g in 1 TUBECREAM857
0178-0320-03Theragesic1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0320-03GM - Gram0178-0320328cb5be-ae2e-4347-ae09-ab2e2f5e9e0712013-10-17
0178-0320-05GM - Gram0178-03200624c2d0-415a-49c3-a0bb-c0826bc8e28e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
CARBOMER 934INACTIVE INGREDIENTZ135WT92081
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0178-03200178-0320-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 934Z135WT9208IACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM LAURYL SULFATE368GB5141JIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheragesicMETHYL SALICYLATEMission Pharmacal Companydb6c0c77-0a20-d574-a98f-e6c9998b941f2025-12-17WarningsExact identifier
ndc (package): 0178-0320-03
ndc (product): 0178-0320
ndc11 (package): 00178032003
spl id: 462d3c9c-2c14-0f71-e063-6294a90a0f40
spl set id: db6c0c77-0a20-d574-a98f-e6c9998b941f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.