Otc - Active Ingredient
Menthol 2.5%
Careall Musle And Joint Gel
FDA Label NDC 51824-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Musle And Joint (NDC 51824-014). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analegesic
Otc - Keep Out Of Reach Of Children
Keep out of Reach of Children. If swallowed, get medical help of contact a Poison Control Center immediately.
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, and bruises
Warnings
For External Use Only.
Do not use:
On wounds or damaged skin
With a heating pad
On children 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 eith eyes or mucous membranes
Do not bandage tightly
Stop use and ask a Doctor if:
Contiditon worsens or symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Excessive skin irritation occurs
Dosage & Administration
Adults 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
Inactive Ingredient
Camphor, Carbomer 980, Isopropyl alcohol, Methylparaben, Polysorbate 60, Potassium Sorbate, Trolamine, Purified water
Otc - Questions
You may report serious side effects / Distributed by: NWI, Inc., 160 Athens Way, Nashville,TN 37228. (615)329-1906
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