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  5. Label Information: Muscle Rub

FDA Label for Muscle Rub

View Indications, Usage & Precautions

Table of Contents

    1. • ACTIVE INGREDIENT
    2. • PURPOSE
    3. • USES
    4. • WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. • DIRECTIONS
    11. • OTHER INFORMATION
    12. • INACTIVE INGREDIENTS
    13. OTHER
    14. PRINCIPAL DISPLAY PANEL - 85 G TUBE CARTON

Muscle Rub Product Label

The following document was submitted to the FDA by the labeler of this product Galentic Pharma (india) Private Limited. 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.

• Active Ingredient



Menthol 10%

Methyl Salicylate 15%


• Purpose



Topical analgesic


• Uses



Temporarily relieves the minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains.

• Warnings



For external use only


Do Not Use



  • On wounds or damaged skin
  • With a heating pad
  • On a child under 12 years of age with arthritis-like conditions

Ask A Doctor Before Use If You Have



  • redness over the affected area

When Using This Product



  • Avoid contact with eyes or mucous membrane
  • Do not bandage tightly

Stop Use And Ask A Doctor If



  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children



• KEEP OUT OF REACH OF CHILDREN

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


• Directions



  • Use only as directed
  • Adults and children 12 years of age and older; apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor

• Other Information



  • Store at 15° to 25 °C (59° to 77°F)
  • Lot No. & Exp. Date : See box or see crimp of tube

• Inactive Ingredients



Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine


Other



Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India


Principal Display Panel - 85 G Tube Carton



Galentic

Muscle Rub
ULTRA STRENGTH

Pain Relieving Cream
Non-Greasy

NET WT.
3 OZ. (85g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton - muscle 01

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton - muscle 01


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