Otc - Active Ingredient
Menthol
Methyl Salicylate
Careall Muscle Rub Cream
FDA Label NDC 51824-007
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 Muscle Rub (NDC 51824-007). 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center Immediately.
Indications & Usage
Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings
For external use only
Do not use:
On wounds or damaged skin
With a heating pad
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 membrane
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
Dosage & Administration
Use only as directed
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
Inactive Ingredient
Citric Acid, Glyceryl Monostearate, lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine
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