SOFSKIN ICE ANALGESIC- menthol gel

Sofskin Ice Analgesic by

Drug Labeling and Warnings

Sofskin Ice Analgesic by is a Otc medication manufactured, distributed, or labeled by Nova Petroleum & Chemicals Corporation, Kim Chemicals LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Label for

NOVA PETROLEUM & CHEMICALS CORP.

Ice Analgesic Gel

Drug Facts:

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)

INGREDIENTS AND APPEARANCE

SOFSKIN ICE ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52069-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.27 g  in 227 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52069-104-07	227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/10/2010

Labeler - Nova Petroleum & Chemicals Corporation (831871731)

Establishment
Name	Address	ID/FEI	Business Operations
Kim Chemicals LTD		650470164	MANUFACTURE