ICE QUAKE PLUS- methyl salicylate, menthol, camphor 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]

ACTIVE INGREDIENT

Active Ingredients               Purpose

Methyl Salicylate  10%      Topical Analgesic

Menthol 10%                    Topical Analgesic

Camphor 3.1%                 Topical Analgesic

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

temporarily relieves minor pain associated with

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

WARNINGS

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 the eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• if sever 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 REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• adults and children over 12 years:
• apply to affected
• squeeze desired amount of IceQuake Plus onto affected area
• massage dispensed gel into painful area until thoroughly absorbed
• repeat as necessary, but no more than 3 to 4 times daily

INACTIVE INGREDIENT

Inactive ingredients: HPMC, glycerin, FD&C Blue No.1, carbopol, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, water

QUESTIONS

SSS Group, LLC Miami, Fl 33183

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ICE QUAKE  PLUS
methyl salicylate, menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-266
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-266-04	113 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)