Theragesic Creme description, usages, side effects, indications, overdosage, supplying and lots more!

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Theragesic Creme

Proficient Rx LP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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

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

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 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 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.

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

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

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.

Uses

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 ingredients

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

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

Westlake Village, CA 91362

Theragesic Creme

METHYL SALICYLATE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63187-078(NDC:0178-0320)
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
methyl salicylate METHYL SALICYLATE 150 mg
MENTHOL 10 mg

Inactive Ingredients

Ingredient Name Strength
water
DIMETHICONE
GLYCERIN
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
TROLAMINE
METHYLPARABEN
SODIUM LAURYL SULFATE
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 85 in 1 TUBE
2 NDC:63187-078-85 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 1981-01-01


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