Label: ZIMS MAX FREEZE- menthol and lidocaine patch
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Contains inactivated NDC Code(s)
NDC Code(s): 66902-213-03, 66902-213-04, 66902-213-06 - Packager: NATURAL ESSENTIALS, 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 March 16, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
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Warnings
For external use only
Do not use
- if you are allergic to any ingredient in Zim's Max-Freeze Patches
- if you have had an allergic reaction to aspirin or other salicylate products
- on open wounds, damaged or irritated skin
- in large quantities, particularly on raw surfaces or blistered areas.
Ask a doctor or pharmacist before use if you are
- using blood thinning medications, steroids or non-steroidal anti-inflammatory drugs (NSAIDS)
When using this product
- a do not use other topical products
- do not use with heating devices
- avoid contact with eyes or mucous membranes
- do not bandage tightly
- keep away from excessive heat
- Directions
- Other information
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Inactive ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Aluminum Hydroxide, Amica Extract, Bomeol, Camphor, EDTA-2Na, Glycerin, Methyl Salicylate, NP-700, PVPP, Tartaric Acid, Titanium Dioxide, Water.
Distributed by Perfects Products. Inc., North Lima. Ohio 44452
(800) 319-2225 • www.ZimsUSA.com
©2016 Perfects Products, Inc.® Made in China
- Principal Display Panel - Canister Label
- Principal Display Panel - Patch Label
- Principal Display Panel - Canister Label
- Principal Display Panel - Patch Label
- Principal Display Panel - Canister Label
- Principal Display Panel - Patch Label
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INGREDIENTS AND APPEARANCE
ZIMS MAX FREEZE
menthol and lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-213 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALCOHOL (UNII: 3K9958V90M) ARNICA MONTANA (UNII: O80TY208ZW) BORNEOL (UNII: M89NIB437X) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) COPOVIDONE K25-31 (UNII: D9C330MD8B) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-213-06 6 in 1 CANISTER 1 1 in 1 PATCH; Type 0: Not a Combination Product 2 NDC:66902-213-04 4 in 1 CANISTER 2 1 in 1 PATCH; Type 0: Not a Combination Product 3 NDC:66902-213-03 3 in 1 CANISTER 3 1 in 1 PATCH; 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 01/01/2016 Labeler - NATURAL ESSENTIALS, INC. (947484713) Establishment Name Address ID/FEI Business Operations NATURAL ESSENTIALS, INC. 947484713 MANUFACTURE(66902-213) , REPACK(66902-213)
