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Drug Facts
Theracare Muscle And Joint Gel
FDA Label NDC 71101-129
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Muscle And Joint Gel (NDC 71101-129). 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, active ingredient, purpose, uses, warnings, do not use, when using this product, do not, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 2.5%
Purpose
- Topical Analgesic
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with:
■ simple backache
■arthritis
■strains
■bruises
■sprains
Warnings
For external use only
Do Not Use
On wounds or damage skin
When Using This Product, Do Not
When using this product:
■ avoid contact with eyes
■do not bandage tightly
Stop Use And Ask A Doctor If
Stop use and ask a doctor if: the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again withing a few days.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help orcontact a Poison Control Center (800-222-1222) right away.
Directions
Directions
- Adults and children 2 years of age and older apply to the affected area not more than 3 to 4 times daily
- Children under 2 years of age: do not use, ask a doctor
Other Information
- store at room temperature
- do not use if tube seal under cap is broken
Inactive Ingredients
carbomer, cinnamomum camphora (camphor) bark oil, ethylhexylglycerin, glycerin, isopropyl alcohol, methylparaben, polysorbate 20, propylparaben, sodium hydroxide, water
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