ARTICO ICE- menthol gel 
World Perfumes, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ingredients - Menthol 1%

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.

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

label image

ARTICO ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10095-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10095-002-01255 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/04/2015
Labeler - World Perfumes, Inc (101312044)
Establishment
NameAddressID/FEIBusiness Operations
World Perfumes, Inc101312044manufacture(10095-002)

Revised: 4/2015
Document Id: 83cb365a-f757-4aae-bf59-c52a5cf5bd35
Set id: db542210-9ee7-40d4-8fff-253511281f86
Version: 1
Effective Time: 20150430
 
World Perfumes, Inc