Artico Ice by Caribe Natural, Inc / World Perfumes, Inc ARTICO ICE- menthol gel

Artico Ice by

Drug Labeling and Warnings

Artico Ice by is a Otc medication manufactured, distributed, or labeled by Caribe Natural, Inc, World Perfumes, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ingredients - Menthol 1%

PURPOSE

USES - Provides temporary relief of minor aches and pains in muscles and joints associated with simple backache, strains, sprains, arthritis and sports injuries.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

Gel Del Artico

Perfect Purity

Soothing Analgesic Gel

Fast, Temporary Relief from Muscle Aches & Pains

Greaseless

Gel Del Artico is a cool, greaseless pain reliever.  It penetrates deep into skin for fast, temporary relief of minor aches and pains in muscles and joints. It provides cooling, soothing relief that last for hours.

WARNINGS

Warnings - For external use only. Not for internal use. Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams ointments, sprays or liniment. Do not bandate.

Do not use with heating pads or heating devices. If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician. If you have sensitive skin, consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spill near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

INACTIVE INGREDIENT

Inactive Ingredients - water, isopropyl alcohol, propylene glycol, carbomer, sodium hydroxide, camphor, dmdm hydantoin, edta, fd&c blue #1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTICO ICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59561-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59561-102-41	255 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/04/2015

Labeler - Caribe Natural, Inc (624210480)

Establishment
Name	Address	ID/FEI	Business Operations
World Perfumes, Inc		101312044	manufacture(59561-102)