ICE QUAKE WHITE- methyl salicylate, menthol cream

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]

ACTIVE INGREDIENT

Active Ingredients               Purpose

Methyl Salicylate  8%      Topical Analgesic

Menthol 2%                    Topical Analgesic

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints due to

• arthritis
• simple backache
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only

When using this product: Use only as directed

• avoid contact with the eyes and mucous membranes
• do not bandage tightly
• do not apply to wounds or damaged skin
• do not use with heating devices
• do not apply to irritated skin
• if pregnant or breast feeding, ask a health prodessional before us

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• adults and children 2 years of age and older; apply generously to affected area massage into painful area until thoroughly absorbed into skin. Repeat if necessary but not more than 3 to 4 times daily. 

INACTIVE INGREDIENT

Inactive ingredients: mineral oil, propylene glycol, cetyl stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 Cetyl/stearyl ether, methylparaben, propylparaben

QUESTIONS

SSS Group, LLC Miami, Fl 33183

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ICE QUAKE  WHITE
methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-688
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
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CETEARETH-6 (UNII: 2RJS3559D3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-688-05	60 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2013

Labeler - Gadal Laboratories Inc (841305639)