Thera-gesic ®

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (150 mg) Menthol (10 mg)

Inactive Ingredients

Water Dimethicone Glycerin Carbomer 934 Trolamine Methylparaben Sodium Lauryl Sulfate Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 1981-01-01

Medication Information

Warnings and Precautions

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 ^®.

Indications and Usage

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).

Description

Drug Facts Active Ingredients Purpose Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant

Section 42232-9

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

Section 43678-2

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.

Section 50565-1

Keep out of reach of children to avoid accidental poisoning.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7

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 ^®

Section 50569-3

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

Section 50570-1

Do not use

immediately shower or bath
if skin is sensitive to oil of wintergreen (methyl salicylate)
on wounds or damaged skin

Section 51727-6

Inactive ingredients

Section 53413-1

Questions(210) 696-8400 (M-Th 8:00-5:30 CST)

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1

Use

temporary relief of minor aches and pains of muscles and joints associated with:

arthritis
simple backaches
strains
bruises
sprains

Section 55106-9

Drug Facts

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

Thera Gesic 3 Oz

Structured Label Content

Indications and Usage (34067-9)

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).

Warnings and Precautions (34071-1)

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 ^®.

Section 42232-9 (42232-9)

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

Section 43678-2 (43678-2)

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.

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)

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 ^®

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

immediately shower or bath
if skin is sensitive to oil of wintergreen (methyl salicylate)
on wounds or damaged skin

Section 51727-6 (51727-6)

Inactive ingredients

Section 53413-1 (53413-1)

Questions(210) 696-8400 (M-Th 8:00-5:30 CST)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)

Use

temporary relief of minor aches and pains of muscles and joints associated with:

arthritis
simple backaches
strains
bruises
sprains

Section 55106-9 (55106-9)

Drug Facts

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

Thera Gesic 3 Oz (THERA-GESIC 3-oz)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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).", "34071-1": "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 ® .", "42232-9": "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", "43678-2": "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.", "50565-1": "Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50567-7": "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 ®", "50569-3": "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", "50570-1": "Do not use immediately shower or bath if skin is sensitive to oil of wintergreen (methyl salicylate) on wounds or damaged skin", "51727-6": "Inactive ingredients", "53413-1": "Questions (210) 696-8400 (M-Th 8:00-5:30 CST)", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Use temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backaches strains bruises sprains", "55106-9": "Drug Facts Active Ingredients Purpose Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information