Theragesic Plus
FDA Label NDC 0178-0350

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mission Pharmacal Company for the product Theragesic Plus (NDC 0178-0350). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

Active IngredientsPurpose
Methyl Salicylate 25%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant
Menthol 4%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic

Otc - 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® PLUS.

Otc - 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

Otc - 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

Otc - 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® PLUS

Otc - 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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 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® 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

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

Inactive ingredients

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

Otc - Questions

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

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® 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

Theragesic-plus-carton (Theragesic Plus Carton)

Theragesic-plus-carton (Theragesic Plus Carton)

Theragesic-plus-carton--0178-0350-03 (Theragesic Plus Carton 0178 0350 03)

Theragesic-plus-carton--0178-0350-03 (Theragesic Plus Carton 0178 0350 03)

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