Otc - Active Ingredient
Menthol 2.667%
Pain Release Joint And Arthritis Cream
FDA Label NDC 70983-028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saje Natural Business Inc. for the product Pain Release Joint And Arthritis Cream (NDC 70983-028). 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, indications & usage, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
topical analgesic
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
Directions For people aged 13 and above: Apply to affected area not more than 3-4 times daily.
Storage And Handling
Store at room temperature and protect from light.
Inactive Ingredient
Inactive Ingredients Butyrospermum parkii (shea) butter, cetearyl alcohol, cetearyl olivate, copaifera officinalis (balsam copaiba) resin oil, glycerin, glyceryl caprylate, glyceryl undecylenate, origanum majorana (marjoram) leaf oil, pentylene glycol, phenethyl alcohol, propanediol, simmondsia chinensis (jojoba) seed oil, sorbitan olivate, stearic acid, theobroma cacao (cocoa) seed butter, water.
Warnings
Warnings
For external use only. Avoid contact with the eyes. Do not apply • to wounds • on damaged skin • and bandage tightly. Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days.
Otc - Stop Use
Discontinue use of this product and consult a doctor if • condition worsens • if symptoms persist for more than 7 days • clear up and occur again within a few days.
Otc - Do Not Use
Do not apply • to wounds • on damaged skin • and bandage tightly.
Otc - When Using
For external use only. Avoid contact with the eyes.
Package Label.Principal Display Panel
Pain Release Joint Cream Outer Box Label (1)
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