FDA Label for Sofskin Ice Analgesic

View Indications, Usage & Precautions

Sofskin Ice Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Nova Petroleum & Chemicals Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



Menthol 1%


Purpose:



Topical Analgesic


Uses



Provide temporary relief of minor aches and pains in muscles and joints associated with samples backache, strains, sprains, arthritis sports injuries.


Warnings



For external use only-Not for internal use.

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged skin. Make sure skin is clean and free from any creams, ointments, sprays or liniment. Do not bandage.


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 consults your doctor before use. Do not use, store, pour or spill near heat or open flames. Store in a cool, dry place and keep lid tightly closed.


Directions



Clean skin of all other lotions, creams, ointments, liniment or sprays, Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years of age.

            Made in India

Imported by:

      Nova Petroleum & Chemicals Corp.

      3 Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533

      www.novawax.com

Distributed by: 

      Vini Health and Beauty Products Inc.

      3 Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533


Principal Display Panel



Sofskin
Ice analgesic gel
Fast, temporary relief from muscle aches and pains
Net Wt. 7 Oz. (200 g)


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