Active Ingredient
Menthol 2.5%
Muscle And Joint
FDA Label NDC 53943-993
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart, Inc. for the product Muscle And Joint (NDC 53943-993). 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, when using this product, stop use and ask a doctor if, keep out of reach of children to avoid accidental ingestion., 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
- with a heating pad
- if you are allergic any of the ingredients
- 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 membranes
- 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
Keep Out Of Reach Of Children To Avoid Accidental Ingestion.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- 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 20° to 25°C (68° to 77°F)
Inactive Ingredients
camphor, carbomer, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, trolamine
Package Label
Muscle & Joint Pain Relief Gel
Muscle.ge.carton (Muscle.gel.carton)
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