Label: ARTICO ICE- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10095-002-01 - Packager: World Perfumes, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 30, 2015
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARTICO ICE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10095-002 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:10095-002-01 255 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 - World Perfumes, Inc (101312044) Establishment Name Address ID/FEI Business Operations World Perfumes, Inc 101312044 manufacture(10095-002)
