Active Ingredient
Menthol 10%
Methyl Salicylate USP 15%
Muscle Rub Cream
FDA Label NDC 87236-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Muscle Rub (NDC 87236-005). 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 active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For the temporary relief of 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
When Using This Product
- avoid contact with eyes
- do not bandage tightly
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
- Children under 2 years of age: Consult a doctor
Other Information
■ Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal ■ Store at room temperature ■ See crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients
Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum
* Please review the disclaimer below.
