BLUE ICE ANALGESIC- menthol gel

Blue Ice Analgesic by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Menthol 2.0%

Purpose

Topical analgesic

Uses

• for the temporarily relief of minor aches and pains of muscles and joints

Warnings

For external use only

When using this product

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

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days

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

• 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: consult a doctor

Inactive ingredients

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

Delon 8oz (227g)

Penetro 227g

INGREDIENTS AND APPEARANCE

BLUE ICE ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61734-021
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
THYMOL (UNII: 3J50XA376E)
AMMONIA (UNII: 5138Q19F1X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
CARBOMER 934 (UNII: Z135WT9208)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61734-021-01	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/07/2010	11/06/2017
2	NDC: 61734-021-02	113.56 g in 1 CONTAINER; Type 0: Not a Combination Product	05/07/2010	12/04/2014
3	NDC: 61734-021-03	227 g in 1 CONTAINER; Type 0: Not a Combination Product	05/07/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/07/2010

Labeler - Delon Laboratories (1990) Ltd (248364184)

Establishment
Name	Address	ID/FEI	Business Operations
Delon Laboratories (1990) Inc.		243387722	manufacture(61734-021) , pack(61734-021) , label(61734-021)