BLUE ICE ANALGESIC GEL- menthol gel

Blue Ice Analgesic Gel by

Drug Labeling and Warnings

Blue Ice Analgesic Gel by is a Otc medication manufactured, distributed, or labeled by Select Brand Distributors, Delon Laboratories (1990) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 2.0%

Uses

• Temporary relief of minor aches and pains in: muscles and joints.

Directions

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 of age and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily.

Warnings

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

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.

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.

PRINCIPAL DISPLAY PANEL

Purpose

• Analgesic.

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, CARBOMER, THYMOL, AMMONIUM HYDROXIDE, SODIUM HYDROXIDE, MAGNESIUM SULFATE, FD&C BLUE 1.

Keep out of reach of children

• In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

INGREDIENTS AND APPEARANCE

BLUE ICE ANALGESIC GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-452
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	88.05 g  in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	8.91 g  in 100 g
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)	0.667 g  in 100 g
THYMOL (UNII: 3J50XA376E)	0.2 g  in 100 g
AMMONIA (UNII: 5138Q19F1X)	0.06 g  in 100 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.1 g  in 100 g
MAGNESIUM SULFATE (UNII: DE08037SAB)	0.01 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.003 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-452-08	227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/06/2014

Labeler - Select Brand Distributors (043562370)

Establishment
Name	Address	ID/FEI	Business Operations
Delon Laboratories (1990) Ltd		243387722	label(15127-452) , manufacture(15127-452) , pack(15127-452)