Muellergesic
FDA Label NDC 52564-312

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mueller Sports Medicine Llc for the product Muellergesic (NDC 52564-312). 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 other, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, 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

Other

Drug Facts

Extremely Flammable:
Keep from heat and flame

Otc - Purpose

Active ingredientPurpose
Menthol 12%Pain Relief
Camphor 6%Pain Relief

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, wrap, hot water bottle or any heating element.

Otc - When Using

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Otc - Stop Use

Discontinue 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 - Keep Out Of Reach Of Children

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away

Otc - Pregnancy Or Breast Feeding

  • if pregnant or nursing, seek the advice of a health professional before using

Directions

  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
  • Children under 12 years of age consult a physician
  • Apply a thin layer to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive Ingredients

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate

Principal Display Panel - 106 G Bottle Label

MUELLER®

Muellergesic®
Cream
topical analgesic

Cooling Menthol &
Camphor relieves
muscle and joint pain

HELPS TO RELIEVE PAIN
ASSOCIATED WITH

  • Strains
  • Sprains
  • Muscle Aches & Pain
  • Arthritis
  • Joint Pain

    • Timed-Release
    IcePearls™

    6h

    NET WT 3.75 OZ (106 g)

    31200 LBL31200A - 9.16

    Principal Display Panel (106 g Bottle Label)

    Principal Display Panel (106 g Bottle Label)

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