NDC | 54273-008-01, 54273-008-02 |
Set ID | 08dcfa78-7332-4f19-90d7-fdd7d446848a |
Category | HUMAN OTC DRUG LABEL |
Packager | KOBAYASHI Healthcare International, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Rare cases of burns have been reported with products of this type
Flammable
- keep away from fire or flame and heated surfaces
- do not use near sparks or while smoking
- do not use in a small or confined space
- avoid long term storage above 104° F (40° C)
- do not puncture or incinerate. Contents under pressure.
- do not expose to temperature exceeding 119° F (48° C)
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
- near face
- 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
- avoid inhalation
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 96 g Can Label
-
INGREDIENTS AND APPEARANCE
ZIMS MAX FREEZE PRO FORMULA
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54273-008 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 160 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA (UNII: O80TY208ZW) VANILLYL BUTYL ETHER (UNII: S2ULN37C9R) TEA TREE OIL (UNII: VIF565UC2G) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54273-008-01 96 g in 1 CAN; Type 0: Not a Combination Product 09/24/2018 2 NDC:54273-008-02 116 g in 1 CAN; 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 NOT FINAL part348 09/24/2018 Labeler - KOBAYASHI Healthcare International, Inc. (156391729)