Muscle Rub
FDA Label NDC 47046-160

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd for the product Muscle Rub (NDC 47046-160). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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