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  5. Label Information: Theragesic Plus

FDA Label for Theragesic Plus

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE FORMS & STRENGTHS
    11. INDICATIONS & USAGE
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PRECAUTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theragesic Plus Product Label

The following document was submitted to the FDA by the labeler of this product Mission Pharmacal Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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