Label: MEDIC ICE- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62001-0318-1, 62001-0318-2, 62001-0318-3, 62001-0318-4, view more62001-0318-5 - Packager: Straight Arrow Products, Inc.
- Category: HUMAN OTC DRUG LABEL
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 September 27, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
- For external use only
Do not use
- on wounds or damaged skin
- with heating pads or heating devices
- with other ointments, creams, sprays or liniments
- with tight bandages
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DOSAGE & ADMINISTRATION
Directions
- Adults and children 2 years and over: Clean skin of all other ointments, creams, sprays or liniments. Apply directly to affected areas no more than 3 to 4 times daily. Wash hands after application to help avoid contact with eyes and sensitive areas. May be used with wet or dry bandages or with ice packs.
- Children under 2 years of age: ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients Water, Alcohol, Laureth-4, Carbomer, Triethanolamine, Aloe Vera, Benzocaine, Thymol, Camphor, Methylsulfonylmethane (MSM), Glucosamine HCl, Chondroitin Sulfate, Oil Complex - (Oregano, Eucalyptus, Sage, Patchouli, Lavender, Rosemary, Ginger, Peppermint), Fragrance, Mineral Complex - (Magnesium Sulfate, Copper Sulfate, Calcium Sulfate, Calcium Carbonate, Lithium Chloride, Potassium Chloride, Sodium Sesquicarbonate, Ammonium Chloride), Herbal Complex - (Arnica, Slippery Elm, Chickweed, Comfrey, Myrrh, Hops, Marshmallow, Plantain, Green Tea), FD and C Blue No. 1.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDIC ICE
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62001-0318 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .07 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) BENZOCAINE (UNII: U3RSY48JW5) LAURETH-4 (UNII: 6HQ855798J) THYMOL (UNII: 3J50XA376E) ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8) ALOE (UNII: V5VD430YW9) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) PEPPERMINT OIL (UNII: AV092KU4JH) EUCALYPTUS OIL (UNII: 2R04ONI662) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ROSEMARY OIL (UNII: 8LGU7VM393) PATCHOULI OIL (UNII: F3IN55X5PO) GINGER OIL (UNII: SAS9Z1SVUK) SAGE OIL (UNII: U27K0H1H2O) OREGANO (UNII: 0E5AT8T16U) GLUCOSAMINE (UNII: N08U5BOQ1K) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) LITHIUM CHLORIDE (UNII: G4962QA067) POTASSIUM CHLORIDE (UNII: 660YQ98I10) CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) AMMONIUM CHLORIDE (UNII: 01Q9PC255D) CALCIUM SULFATE (UNII: WAT0DDB505) CALCIUM CARBONATE (UNII: H0G9379FGK) ARNICA MONTANA (UNII: O80TY208ZW) ELM (UNII: 63POE2M46Y) STELLARIA MEDIA (UNII: 2H03479QVR) COMFREY (UNII: D05HXK6R3G) MYRRH (UNII: JC71GJ1F3L) HOPS (UNII: 01G73H6H83) PLANTAGO MAJOR (UNII: W2469WNO6U) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62001-0318-1 318880.8 g in 1 CONTAINER 2 NDC:62001-0318-2 454 g in 1 CONTAINER 3 NDC:62001-0318-3 71 g in 1 TUBE, WITH APPLICATOR 4 NDC:62001-0318-4 113 g in 1 TUBE 5 NDC:62001-0318-5 4 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/24/2004 Labeler - Straight Arrow Products, Inc. (061580593) Registrant - Straight Arrow Products, Inc. (061580593) Establishment Name Address ID/FEI Business Operations Straight Arrow Products, Inc. 061580593 manufacture