Label: ZIMS MAX FREEZE- menthol, lidocaine and menthyl salicylate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 66902-113-03, 66902-113-04, 66902-113-06 - Packager: NATURAL ESSENTIALS, 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 February 10, 2016
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- ACTIVE INGREDIENTS:
- PURPOSE:
- *USES:
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WARNINGS:
Use only as directed.
- For external use only
- Do Not use if you are allergic to any ingredient in Zim's Max-Freeze Patch
- Do Not use if you have had allergic reaction to aspirin or other salicylate products
- Use caution with blood thinning medications, NSAIDS, steroids or nonsteroidal anti-inflammatory drugs
- If conditions worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician
- Avoid contact with eyes or mucous membranes
- DIRECTIONS:
- OTHER:
- INACTIVE INGREDIENTS:
- Principal Display Panel - Medium Pouch Label
- Principal Display Panel - Large Pouch Label
- Principal Display Panel - Extra Large Pouch Label
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INGREDIENTS AND APPEARANCE
ZIMS MAX FREEZE
menthol, lidocaine and menthyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-113 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)- 0.4 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-113-06 6 in 1 CANISTER 1 1 in 1 POUCH 1 1 in 1 PATCH; Type 0: Not a Combination Product 2 NDC:66902-113-04 4 in 1 CANISTER 2 1 in 1 POUCH 2 1 in 1 PATCH; Type 0: Not a Combination Product 3 NDC:66902-113-03 3 in 1 CANISTER 3 1 in 1 POUCH 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(66902-113)