Drug Facts Active Ingredient
Drug facts
Active ingredient: purpose
Menthol 4% Topical Analgesic
The following Structured Product Label (SPL) was submitted to the FDA by Ion Pharma, Llc for the product Sync Ice (NDC 82944-300). 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, uses, warnings, when using this product, stop use section, if pregnant or breast-feeding section, keep out of reach of children, directions section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug facts
Active ingredient: purpose
Menthol 4% Topical Analgesic
Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains
Warnings:
For external use only
Flammable: Keep away from excessive heat or open flame
Ask a doctor before use if you have: Sensitive skin
When using this product:
Stop use and ask a doctor if:
Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur
If pregnant or breast-feeding: Ask a healthcare professional before use
Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions:
Adults and children 12 years of age and older: Rub a thin
thin film over not more than 4 times daily mass; massage
not necessary
Children under 12 years of age: Consult physician
Inactive Ingredients:
Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water.
Questions or Comments:
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