ICE QUAKE PLUS- methyl salicylate, menthol, camphor cream

Ice Quake by

Drug Labeling and Warnings

Ice Quake by is a Otc medication manufactured, distributed, or labeled by Southern Sales & Service, Inc., 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

Uses

temporarily relieves minor pain associated with

• Arthritis
• Smple backache
• Strains
• Bruises
• Pprains
• Cramps

Warnings

For external use only

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

Stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops

When using this product:

• Use only as directed
• Do not bandage tightly
• Do not use with a heating devices
• Avoid contact with the eyes and mucous membranes
• Do not apply to wounds, 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

Keep out of reach of children.

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

Directions

• adults and children over 18 years and older:
• Apply to affected area
• Squeeze desired amount of IceQuake Plus onto affected area
• massage dispensed cream 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

DISTRIBUTE BY:

SSS Group, LLC Pembroke Pines, Fl 33332

Questions or Comments?

Call 1 800.213.9370

ICE QUAKE PLUS

INGREDIENTS AND APPEARANCE

ICE QUAKE  PLUS
methyl salicylate, menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-101
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: 69822-101-04	113 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/01/2013

Labeler - Southern Sales & Service, Inc. (013114906)

Establishment
Name	Address	ID/FEI	Business Operations
Southern Sales & Service, Inc.		013114906	LABEL(69822-101)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(69822-101)