Label: SOFSKIN ICE ANALGESIC- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52069-104-07 - Packager: Nova Petroleum & Chemicals Corporation
- 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
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose:
- Uses
- Warnings
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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.
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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
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INGREDIENTS AND APPEARANCE
SOFSKIN ICE ANALGESIC
menthol gelProduct 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