Sofskin Ice Analgesic

Dosage form: gel
Ingredients: MENTHOL 2.27g in 227g
Labeler: Nova Petroleum & Chemicals Corporation
NDC Code: 52069-104

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Ice Analgesic Gel

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)

SOFSKIN ICE ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52069-104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.27 g  in 227 g
Packaging
#Item CodePackage Description
1NDC:52069-104-07227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/10/2010
Labeler - Nova Petroleum & Chemicals Corporation (831871731)
Establishment
NameAddressID/FEIOperations
Kim Chemicals LTD650470164MANUFACTURE

Revised: 03/2010
 
Nova Petroleum & Chemicals Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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