ICE QUAKE MUSCLE RUB- 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]

ACTIVE INGREDIENT

Active Ingredients               Purpose

Menthol 2.0%                    Topical Anagesic

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains
• sport injuries

WARNINGS

Warnings

For external use only

When using this product

• avoid contact with the eyes
• do not bandage tightly
• do not apply to wounds or damaged skin
• do not use with heating pads or ther heating devices

Stop use and ask a doctor if

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

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 to affected area not more than 3 to 4 times daily.
• children under 2 years of age; do not use, consult doctor

INACTIVE INGREDIENT

Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, water

QUESTIONS

SSS Grou, LLC Miami, Fl 33183

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ICE QUAKE  MUSCLE RUB
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-108
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
CARBOMER 940 (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-108-08	228 g in 1 JAR

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)