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  5. Label Information: Muscle Rub

FDA Label for Muscle Rub

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. OTHER
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Muscle Rub Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center Llc. 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



Active Ingredient

Menthol 2.5%


Otc - Purpose



Purpose

Topical Analgesic


Indications & Usage



Uses

  • Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.

Warnings



Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

  • Avoid contact with eyes or mucous membranes.
  • Discontinue use if excessive irritation of the skin develops.
  • Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
  • If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
  • For arthritis like conditions in children under 12, do not use. Consult a doctor.

Otc - Keep Out Of Reach Of Children



  • If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration



Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears.
  • Children under 12 years of age: do not use, consult a doctor

Other



Other Information

  • Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • Lot No. & Exp. Date: see crimp of tube.

Inactive Ingredient



Inactive Ingredients

Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

MUSCLE RUB GEL

NET WT 1.25 OZ (35 g)

image of package label - muscle rub

image of package label - muscle rub


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