Artico Ice
FDA Label NDC 10095-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by World Perfumes, Inc for the product Artico Ice (NDC 10095-002). 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, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Ingredients - Menthol 1%

Otc - Purpose

USES - Provides temporary relief of minor aches and pains in muscles and joints associated with simple backache, strains, sprains, arthritis and sports injuries.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Gel Del Artico

Perfect Purity

Soothing Analgesic Gel

Fast, Temporary Relief from Muscle Aches & Pains

Greaseless

Gel Del Artico is a cool, greaseless pain reliever.  It penetrates deep into skin for fast, temporary relief of minor aches and pains in muscles and joints. It provides cooling, soothing relief that last for hours.

Warnings

Warnings - For external use only. Not for internal use. Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams ointments, sprays or liniment. Do not bandate.

Do not use with heating pads or heating devices. If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician. If you have sensitive skin, consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

Inactive Ingredient

Inactive Ingredients - water, isopropyl alcohol, propylene glycol, carbomer, sodium hydroxide, camphor, dmdm hydantoin, edta, fd&c blue #1

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