Drug Facts Active Ingredient
Menthol 1.25%
Joint Ease Cream
FDA Label NDC 72609-045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smith Amish, Llc for the product Joint Ease (NDC 72609-045). 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 drug facts active ingredient, purpose, uses, warnings, otc - stop use, otc - pregnancy or breast feeding, keep out of reach of children., directions, 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 termporary relief of minor aches and pains of muscles and joints associated with arthritis.
Warnings
For external use only
Avoid contact with eyes
Otc - Stop Use
- If condition worsens, or if symptoms persist for more than 7 days or cler up and occur again within a few days,, discontinue use of this product and consult a doctor. Do not bandage tightly.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.
Other Information
Protect from excessive heat
Store at 20-25 oC (68-77F)
Inactive Ingredients
Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water
Questions?
Call (866) 419-3567
Monday through Friday 8:00am - 2:00pm ET
Other
Tamper evident: Do not use if safety seal under cap is broken or missing.
Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634
Label
Smith Amish Joint Ease Cream (72609-045-04)
Deep Penetrating & Soothing
Gently targets joint & tendon discomfort
Net wt. 4oz (114g)
* Please review the disclaimer below.
