EQUALINE BLUE ICE PAIN RELIEVING- menthol gel

EQUALINE BLUE ICE PAIN RELIEVING by

Drug Labeling and Warnings

EQUALINE BLUE ICE PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                       Purpose

Menthol 2.0% ..........................................................................Topical Analgesic

PURPOSE

Uses: Temporary relief of minor aches and pains in: Muscles and joints.

WARNINGS

Warnings:

For external use only.  Avoid contact with eyes and mucus membranes.

WHEN USING

When using this product do not:

• Use with heating pads or heating devices
• Use, pour, spill, or store near open flame
• Use with other creams, sprays or liniments
• Apply to damaged skin or wounds
• Bandage area tightly

To do so may result in excessive skin irritation or skin burn.

STOP USE

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product

and consult a physician.  If you have sensitive skin, consult a physician.  If skin irritation develops, discontinue use and seek the advice of a physician before

using this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions:

• See important warnings under "When using this product."
• Do not apply to children under 2 years of age, unless advised by a physician
• Adults and children over 2 years and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily
  

INACTIVE INGREDIENT

Inactive Ingredients: Aqua (water), Isopropyl Alcohol, Carbomer, Thymol, Ammonium Hydroxide, Sodium Hydroxide, Magnesium Sulfate, FD and C Blue No.1

DOSAGE & ADMINISTRATION

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 55344 USA

MADE IN CANADA

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

EQUALINE BLUE ICE PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-488
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
THYMOL (UNII: 3J50XA376E)
AMMONIA (UNII: 5138Q19F1X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-488-32	227 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	10/03/2011

Labeler - SUPERVALU INC (006961411)