Theragesic Plus

Manufacturer: Mission Pharmacal Company
Effective date: 2019-08-14
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:00:04

Label at a glance#

ProductTheragesic Plus

Active ingredientMETHYL SALICYLATE, MENTHOL

Label structure15 sections

Contacts and useful links#

PhoneLabel contact(210) 696-8400

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

*Active Ingredients*	*Purpose*
Methyl Salicylate 25%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant
Menthol 4%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic

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 ^® PLUS.

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 ^® PLUS

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 ^® PLUS. 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 ^® PLUS 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

Aloe Vera, Carbomer Homopolymer Type C, Dimethicone, Glycerine, Methylparaben, Propylparaben, Sodium Lauryl Sulfate, Trolamine, Water.

OTC - QUESTIONS SECTION

To Report a serious adverse event or obtain product information, call (210) 696-8400

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 ^® PLUS TO COME IN 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

50564 C03 Rev 001110

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THERA-GESIC ^® PLUS Carton
NDC: 0178-0350-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0178-0350-03	2022-01-28	C162847	48780-1	d6a99b39-d21b-a426-e053-dadaa90af4c2	Theragesic Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0178-0350-03	Theragesic Plus	1 in 1 CARTON	GEL	1		4
0178-0350-03	Theragesic Plus	85 g in 1 TUBE	GEL	85		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-0350	THERAGESIC PLUS (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	4	Legacy NDC, 2 package rows	20190815_6e7bccc8-1823-4b45-d047-f0979a8e0443.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0350-03	GM - Gram	0178-0350	3954b52d-d2e0-4044-beb9-a58dc6035c13	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	1
CARBOMER 934	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.

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

Theragesic Plus
METHYL SALICYLATE
WATER
DIMETHICONE
GLYCERIN
CARBOMER 934
TROLAMINE
METHYLPARABEN
SODIUM LAURYL SULFATE
PROPYLPARABEN
SALICYLIC ACID
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0178-0350	0178-0350-03

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER 934	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

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 5 · 300 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION/ DROPS / OPHTHALMIC	0.4 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SOLUTION / TOPICAL		10 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	CAPSULE / ORAL		32 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION / OPHTHALMIC	0.45 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO, SUSPENSION / TOPICAL	40 %w/v		Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
90156099-9aac-9bd8-e053-2a95a90abca0			6e7bccc8-1823-4b45-d047-f0979a8e0443	2019-08-14	Warnings	Exact identifier spl id: 90156099-9aac-9bd8-e053-2a95a90abca0 spl set id: 6e7bccc8-1823-4b45-d047-f0979a8e0443

Reported adverse events (FAERS/openFDA)#

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