GADADERM FROZEN ICE ADVANCE PAIN RELIEF (salicylic acid menthol camphor- natural gel

GADADERM Frozen Ice Advance Pain Relief by

Drug Labeling and Warnings

GADADERM Frozen Ice Advance Pain Relief by is a Otc medication manufactured, distributed, or labeled by GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active Ingredients	Purpose
Methyl Salicylate 10%	Topical Analgesic
Menthol 10%	Topical Analgesic
Camphor 3.1%	Topical Analgesic

INACTIVE INGREDIENT

Carbopol, Cetearyl Alcohol, Disodium EDTA, FD&C Blue #1, Glycerin, Hydroxypropyl Methylcellulose, Menthylparaben, Propylene Glycol, Propylparaben, Polysorbate 20, Purified Water, Stearic Acid, Sodium Hydroxide.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

WARNINGS

For the external use only. When using this product use as directed.

• Do not bandage tightly or use with heating pad. Avoid contact with eyes and 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 conditions worsen, redness is present, irritation develops.

If swallowed, get medical help or contact a Poison Control Center right away. IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older; apply generously to affected area massage into painful area until thoroughly absorbed into skin. Repeat as necessary but not more than 3 to 4 times daily.

PURPOSE

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

GADADERM Frozen Ice Advance Pain Relief

INGREDIENTS AND APPEARANCE

GADADERM FROZEN ICE ADVANCE PAIN RELIEF 
salicylic acid menthol camphor (natural) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10   in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10   in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3.1   in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-362-09	99 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2016

Labeler - GADAL Laboratories, Inc (841305639)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(53113-362)