Label: ZIMS MAX FREEZE PRO FORMULA- menthol, unspecified form gel
- NDC Code(s): 54273-007-01, 54273-007-02
- Packager: KOBAYASHI Healthcare International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 16, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Rare cases of burns have been reported with products of this type
Do not use
- if you are allergic to any ingredient in this product
- on open wounds, damaged or irritated skin
- with a heating pad or TENS device
- after expiration date
When using this product
- may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
- do not bandage tightly
- do not use otherwise than as directed
- avoid contact with eyes or mucous membranes
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
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INGREDIENTS AND APPEARANCE
ZIMS MAX FREEZE PRO FORMULA
menthol, unspecified form gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54273-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 70 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA WHOLE (UNII: O80TY208ZW) VANILLYL BUTYL ETHER (UNII: S2ULN37C9R) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TEA TREE OIL (UNII: VIF565UC2G) ISOPROPYL ALCOHOL (UNII: ND2M416302) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54273-007-01 85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 08/01/2018 2 NDC:54273-007-02 102 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M017 08/01/2018 Labeler - KOBAYASHI Healthcare International, Inc. (156391729) Registrant - KOBAYASHI America Manufacturing, LLC (079852150) Establishment Name Address ID/FEI Business Operations KOBAYASHI America Manufacturing, LLC 079852150 PACK(54273-007) , LABEL(54273-007)