Theragesic Creme
- Manufacturer
- Proficient Rx LP
- Effective date
- 2019-11-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:58:18
Label at a glance#
ProductTheragesic Creme
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM
Label structure15 sections
Contacts and useful links#
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
- 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 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.
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
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0178-0320-03 | GM - Gram | 0178-0320 | 328cb5be-ae2e-4347-ae09-ab2e2f5e9e07 | 1 | 2013-10-17 |
| 0178-0320-05 | GM - Gram | 0178-0320 | 0624c2d0-415a-49c3-a0bb-c0826bc8e28e | 1 | 2013-10-17 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | INACTIVE INGREDIENT | Z135WT9208 | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Theragesic Creme
- METHYL SALICYLATE
- SALICYLIC ACID
- MENTHOL, UNSPECIFIED FORM
- MENTHOL
- Water
- DIMETHICONE
- GLYCERIN
- CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
- TROLAMINE
- METHYLPARABEN
- SODIUM LAURYL SULFATE
- PROPYLPARABEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63187-078 | 63187-078-85 |
| 0178-0320 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
| Water | 059QF0KO0R | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / TOPICAL | 1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | CREAM / TOPICAL | 600 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Theragesic | METHYL SALICYLATE | Mission Pharmacal Company | db6c0c77-0a20-d574-a98f-e6c9998b941f | 2025-12-17 | Warnings | 0178-0320 |
| b3383b19-80ea-4b64-b769-910cc28d0e74 | 56e88a96-5be0-4a5c-995e-77c807c5294b | 2023-11-01 | Warnings | 56e88a96-5be0-4a5c-995e-77c807c5294b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.