Label at a glance#

ProductTheragesic Creme

Active ingredientMETHYL SALICYLATE, MENTHOL

Label structure16 sections

Contacts and useful links#

PhoneLabel contact(210) 696-8400

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

THERA-GESIC 5-oz

HOW SUPPLIED SECTION

Product: 50090-0430

NDC: 50090-0430-0 85 g in a TUBE / 1 in a CARTON

METHYL SALICYLATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0430-0	2023-01-30	C162847	48780-1	f386c64a-2e7a-0266-e053-dadaa90a7c1a	THERA-GESIC ® Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0430-0	Theragesic Creme	1 in 1 CARTON	GEL	1		13
50090-0430-0	Theragesic Creme	85 g in 1 TUBE	GEL	85		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0430	THERAGESIC CREME (METHYL SALICYLATE) GEL [A-S MEDICATION SOLUTIONS]	13	Legacy NDC, 2 package rows	20210415_af2542d2-e609-4c25-8f12-6ce00836543c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0430-0	GM - Gram	50090-0430	22a51f5a-f0a8-4f58-9b5a-8d0a180b94af	1	2018-09-05
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

Products#

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

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

Theragesic Creme
METHYL SALICYLATE
WATER
DIMETHICONE
GLYCERIN
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
TROLAMINE
METHYLPARABEN
SODIUM LAURYL SULFATE
PROPYLPARABEN
SALICYLIC ACID
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-0430	50090-0430-0
0178-0320

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
Name	UNII	Kind
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
METHYL SALICYLATE	LAV5U5022Y	ACTIB
MENTHOL	L7T10EIP3A	ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier ndc (product): 0178-0320
1e418d6b-0ec2-407d-87bc-2a91ccb5ff50			af2542d2-e609-4c25-8f12-6ce00836543c	2021-04-14	Warnings	Exact identifier spl id: 1e418d6b-0ec2-407d-87bc-2a91ccb5ff50 spl set id: af2542d2-e609-4c25-8f12-6ce00836543c

Reported adverse events (FAERS/openFDA)#

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