THERAGESIC CREME- methyl salicylate gel

Theragesic Creme by

Drug Labeling and Warnings

Theragesic Creme by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

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

PURPOSE

Use

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

• arthritis
• simple backaches
• strains
• bruises
• sprains

WARNINGS

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®.

DO NOT USE

Do not use

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

ASK DOCTOR

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

WHEN USING

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®

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

Dosage and Administration

DOSAGE FORMS & STRENGTHS

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

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

Inactive ingredients

QUESTIONS

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

PRECAUTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERAGESIC CREME 
methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-078(NDC:0178-0320)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-078-85	1 in 1 CARTON	11/01/2018
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/1981

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(63187-078) , RELABEL(63187-078)