Label: SOFSKIN ICE ANALGESIC- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 11, 2010

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  • 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)

    Principal Display Panel Sofskin Ice Anagesic Gel Net Wt. 7 Oz. (200 g)

  • INGREDIENTS AND APPEARANCE
    SOFSKIN ICE ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52069-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.27 g  in 227 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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/FEIBusiness Operations
    Kim Chemicals LTD650470164MANUFACTURE
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