THERA-GESIC ® DUAL-ACTION PAIN RELIEVING CREAM

Manufacturer
Mission Pharmacal Company
Effective date
2026-10-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-27 02:03:01

Label at a glance#

ProductTheragesic
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure12 sections

Dosage and administration

Adults and children 12 or more years of age: Apply thin layers of cream 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 thin layer provides a mild effect, two thin layers provide a strong effect and three thin layers provide a verystrong effect. SEE WARNINGS. Wash hands thoroughly after application.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose
Menthol 1% . . . . . . . . . . . . . . . . . . . . Analgesic
Methyl Salicylate 15% . . . . . . . . . Counterirritant

Use

OTC - PURPOSE SECTION

Temporary relief of minor aches and pains of muscles and joints associated with:
■ arthritis

■ simple backaches

■ strains
■ bruises

■ sprains

Warnings

WARNINGS SECTION

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 after shower or bath

■ on wounds or damaged skin

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use

■ for children under 2 and to 12 years of age

■ if prone or sensitive to allergic reactions 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 breastfeeding, ask a healthcare professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 or more years of age: Apply thin layers of cream 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 thin layer provides a mild effect, two thin layers provide a
strong effect and three thin layers provide a verystrong effect. SEE WARNINGS. Wash hands
thoroughly after application.

Other information

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENT SECTION

Carbopol 974, dimethicone, glycerine, methylparaben,
propylparaben, sodium hydroxide, sodium lauryl sulfate, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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
0178-03200178-0320-33

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsName fallback
generic name: METHYL SALICYLATE
AVON Foot Works Arthritis Achy Foot and MuscleMETHYL SALICYLATECOSMAX USA, CORPORATION56440d3f-bc93-cebb-e063-6294a90a5f792026-07-10WarningsName fallback
generic name: METHYL SALICYLATE
Methyl Salicylate 10%METHYL SALICYLATEION PHARMA, LLC11a6d22a-1a7a-4c76-b873-fffd00ac4b542026-04-28WarningsName fallback
generic name: METHYL SALICYLATE
BeeVenomMETHYL SALICYLATEMenper Distributors, Inc.4fe7a986-336d-ad4e-e063-6294a90a0b8a2026-04-20WarningsName fallback
generic name: METHYL SALICYLATE
FlexSport Roll OnMETHYL SALICYLATEPharmadel LLCbf8de3da-7628-6112-e053-2995a90a8e162026-03-26WarningsName fallback
generic name: METHYL SALICYLATE
Kofal OriginalMETHYL SALICYLATEPharmadel LLC984780fd-496b-150b-e053-2995a90aed772026-03-26WarningsName fallback
generic name: METHYL SALICYLATE
Kofal FuerteMETHYL SALICYLATEPharmadel LLC98488a07-eba0-2b4e-e053-2995a90ad6ab2026-03-26WarningsName fallback
generic name: METHYL SALICYLATE
KofalMETHYL SALICYLATEPharmadel LLC9cac377d-97bc-f0b7-e053-2a95a90a2e122026-03-26WarningsName fallback
generic name: METHYL SALICYLATE
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsName fallback
generic name: METHYL SALICYLATE
Ted and Gregs Pain Rub with Resveratrol Topical AnalgesicMETHYL SALICYLATETed and Greg's Inc.c699438d-595d-4711-801b-51e960aa36682025-12-29WarningsName fallback
generic name: METHYL SALICYLATE
Relief RecoveryMETHYL SALICYLATEMayway Corporation27afd45e-2dc5-d099-e063-6394a90ad2b72025-12-23WarningsName fallback
generic name: METHYL SALICYLATE
MobilityMETHYL SALICYLATEMayway Corporation27af9d17-9c15-5e2a-e063-6394a90aeda52025-12-23WarningsName fallback
generic name: METHYL SALICYLATE
Methyl SalicylateMETHYL SALICYLATEALAINA HEALTHCARE PRIVATE LIMITEDe07c5ebc-5497-4c45-acc5-d12e72e98f3f2025-12-09WarningsName fallback
generic name: METHYL SALICYLATE
Methyl Salicylate 40% Topical OilMETHYL SALICYLATEFORREAL PHARMACEUTICALS LLC10e15734-9783-4153-b7b6-a4d0f57678b62025-10-07WarningsName fallback
generic name: METHYL SALICYLATE
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsName fallback
generic name: METHYL SALICYLATE
Methyl Salicylate 25% CreamMETHYL SALICYLATEAdvanced Rx of Tennessee, LLC3bdd3015-349a-0fac-e063-6394a90afe412025-08-08WarningsName fallback
generic name: METHYL SALICYLATE
La Flecha JaponesaMETHYL SALICYLATEMenper Distributors, Inc.08819ad0-97c2-49bd-b923-535b94a271672025-07-22WarningsName fallback
generic name: METHYL SALICYLATE
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMenper Distributors Inc.ad940dc8-9403-44cf-aed3-6e538cbe488b2025-07-22WarningsName fallback
generic name: METHYL SALICYLATE
Balsamo de Vaca MascuraMETHYL SALICYLATEMenper Distributors Inc.321b6f1f-c802-4b96-99d3-e77217da11a32025-07-22WarningsName fallback
generic name: METHYL SALICYLATE
Abejas y Viboras Roll OnMETHYL SALICYLATEMenper Distributors Inc.bedf3b36-7def-099f-e053-2a95a90ac15b2025-07-22WarningsName fallback
generic name: METHYL SALICYLATE

Reported adverse events (FAERS/openFDA)#

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