ZIMS MAX FREEZE LEG CRAMPS- camphor, menthol patch

ZIMS MAX FREEZE by

Drug Labeling and Warnings

ZIMS MAX FREEZE by is a Otc medication manufactured, distributed, or labeled by KOBAYASHI Healthcare International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Camphor 5%	Topical analgesic
Menthol 5%	Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

• Simple backache
• Arthritis
• Strains
• Bruises
• Sprains
• Cramps

Warnings

For external use only

Do not use

• more than 1 patch on your leg or arm at a time
• if you are allergic to any ingredients in this product
• on open wounds, damaged or irritated skin
• with a heating pad or TENS device or other topical analgesics
• after expiration date

When using this product

• do not bandage tightly
• do not use otherwise than as directed
• avoid contact with eyes or mucous membranes
• may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
• if severe burning sensation occurs, discontinue use immediately
• may leave a blue stain on skin, which is safe and can be removed by washing with soap and water
• avoid adhering patch to clothes or delicate fabrics such as silk

Stop use and ask a doctor if

• burning sensation is painful and persistent
• condition worsens
• rash, itching, redness, swelling, blistering or excessive irritation of the skin develops
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

• clean and dry affected area
• remove film from patch and apply to the skin (see illustration)
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily

Children under 12 years of age:

• consult a doctor

Other information

• store in a place away from direct sunlight and excessive heat and moisture.

Inactive ingredients

Butyl Acrylate/Methacrylic acid copolymer, FD&C Blue No. 1, Glycerin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylparaben, Propylene glycol, Silicon dioxide, Sodium polyacrylate, Sodium polyacrylate starch, Sorbitan monooleate, Sorbitol, Tartaric acid, Water

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Distributed by:
KOBAYASHI Consumer Products, LLC
P.O. Box 1191, Dalton, GA 30722

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

ZIM'S™
MAX-
FREEZE

For Minor Pain Caused by
LEG CRAMPS
COOLING PAIN RELIEF HYDRO PATCH

Immediate Cooling & Long-lasting
Pain Relief
While You Sleep*†

APPLY for
8
Hours

5 PATCHES

3 15/16" X 5 1/2" (10 cm X 14 cm)
†See back panel for important product information

COOLING PAIN RELIEF HYDRO PATCH: Menthol & Camphor with thick Hydrogel

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE   LEG CRAMPS
camphor, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	950 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	950 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) (UNII: Q984S31CYH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SODIUM POLYACRYLATE STARCH (25 MICROMETER PARTICLE) (UNII: KXY4EH7RJV)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54273-013-01	5 in 1 BOX	03/01/2024
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M017	03/01/2024

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)