Ice Quake by Gadal Laboratories, Inc. ICE QUAKE- menthol gel

Ice Quake by

Drug Labeling and Warnings

Ice Quake by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 15%

PURPOSE

Topical analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

Warnings

For external use only.

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• if severe burning sensation occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight.

Stop use and ask a doctor if:

• condition worsens
• redness is present
• irritation develops

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 18 years:

• apply to affected area
• squeeze desired amount of ICEQUAKE onto affected area
• massage dispensed gel into painful area until thoroughly absorbed
• repeat as necessary, but no more than 3 to 4 times daily.

• IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Inactive Ingredients

HPMC, Glycerine, FD&C blue #1, Carbopol, Isopropyl alcohol, Propylene glycol, Methylparaben, Sodium hydroxide, Purified water.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY:
GADAL Laboratories, Inc. Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

ICEQUAKE
Pain Relieving GEL
Menthol
15%

Net wt 4 oz (113 g)

INGREDIENTS AND APPEARANCE

ICE QUAKE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	16.95 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
Glycerin (UNII: PDC6A3C0OX)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Methylparaben (UNII: A2I8C7HI9T)
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: 53113-100-01	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part348	08/23/2012

Labeler - Gadal Laboratories, Inc. (841305639)

Establishment
Name	Address	ID/FEI	Business Operations
Gadal Laboratories, Inc.		841305639	MANUFACTURE(53113-100)