BLUE ICE PAIN RELIEVING- menthol gel

Blue Ice by

Drug Labeling and Warnings

Blue Ice by is a Otc medication manufactured, distributed, or labeled by Genuine Drugs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol

Capsaicin

Purpose

Pain Reliever

Pain Reliever

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

● arthritis ● simple backache ● strains

● bruises ● sprains

Warnings

For external use only

Do not use

• with other topical pain relievers
• with heating pads or heating devices

When using this product

• avoid contact with the eyes
• use only as directed
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• redness or irritation develops

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean affected area before applying product
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store at room temperature
• keep lid tightly closed
• do not use, pour, spill or store near heat or open flame

Inactive ingredients

ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Package label

Maslac Icy Blue Gel + Capsaicin

INGREDIENTS AND APPEARANCE

BLUE ICE  PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69666-368
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.05 g  in 1 g
capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM)	capsaicin	.00025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMOL (UNII: 3J50XA376E)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69666-368-08	1 in 1 BOX
1		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	03/17/2015

Labeler - Genuine Drugs (079610378)