Theragesic Creme

Manufacturer
Mainpointe Pharmaceuticals, LLC | Mission Pharmacal Company
Effective date
2020-02-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:49

Label at a glance#

ProductTheragesic Creme
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients Purpose
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

if skin is sensitive to oil of wintergreen (methyl salicylate)
immediately shower or bath
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 if condition 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.

OTHER SAFETY INFORMATION

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

Carbomer 934, dimethicone, glycerine, methylparaben, propylparaben, sodium laurel sulfate, trolamine, water

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. MainPointe Pharmaceuticals, LLC Louisville, KY 40202 Rev 50563R1218

INDICATIONS & USAGE 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.

THERA-GESIC 3-oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theragesic cartonTheragesic carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259203menthol 1 % / methyl salicylate 15 % Topical CreamPSN1
724160THERA-GESIC Pain Relieving Creme 1 % / 15 % Topical CreamPSN1
724160menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical Cream [Thera-Gesic]SBD1
259203menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1
259203menthol 1 % / methyl salicylate 15 % Topical CreamSY1
724160Thera-Gesic (menthol 10 MG/ML / methyl salicylate 150 MG/ML) Topical CreamSY1
724160Thera-Gesic Pain Relieving Creme (menthol 1 % / methyl salicylate 15 % ) Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71269-005-032022-01-28C16284748780-1d6a99b39-a1b5-a426-e053-dadaa90af4c2THERA-GESIC ® Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71269-005-03Theragesic Creme85 g in 1 TUBECREAM851
71269-005-03Theragesic Creme1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71269-005THERAGESIC CREME (METHYL SALICYLATE) CREAM [MAINPOINTE PHARMACEUTICALS, LLC]1Legacy NDC, 2 package rows20200225_9f55e38e-03bb-42fc-e053-2a95a90a1378.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71269-005-03GM - Gram71269-0053d1898ac-7853-4892-a1a8-c7368bbc2a2e12021-09-07

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
71269-00571269-005-03

Ingredients#

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

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

Source Document#

Source XML

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
a1889050-a687-40e8-8eef-8fb72a41871d9f55e38e-03bb-42fc-e053-2a95a90a13782026-08-28WarningsExact identifier
spl set id: 9f55e38e-03bb-42fc-e053-2a95a90a1378

Reported adverse events (FAERS/openFDA)#

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