ZIMS MAX FREEZE PRO FORMULA- menthol, unspecified form liquid

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]

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Drug Facts

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

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

• Simple backache
• Arthritis
• Strains
• Bruises
• Sprains

Warnings

For external use only

Flammable

Keep away from fire or flame and heated surfaces

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

• to avoid excess application, press applicator gently against skin
• do not bandage tightly
• do not use otherwise than as directed
• avoid contact with eyes or mucous membranes

Stop use and ask a doctor if

• condition worsens
• rash, itching, redness 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

• apply to affected area not more than 4 times daily

Children under 12 years of age:

• consult a doctor

Other information

• store in a cool place away from direct sunlight
• store with cap closed tightly

Inactive ingredients

†Aloe Barbadensis Leaf Extract, Arnica Extract, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Vanillyl Butyl Ether, Water.

†Symbol before the ingredient indicates certified organic.

QUESTIONS

Consumer Comments Call: 1-800-432-8629

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

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton

ZIM'S™
MAX-
FREEZE
PRO FORMULA

DEEP PENETRATING
PAIN RELIEF

- FAST ACTING
- LONG LASTING
- VANISHING SCENT

Bottle Shaped for
Easy Application

COLD THERAPY
COOLING LIQUID
with 16% Menthol

3 fl oz (89mL)

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE   PRO FORMULA
menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-009
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
TEA TREE OIL (UNII: VIF565UC2G)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54273-009-01	1 in 1 CARTON	08/20/2018
1		89 mL in 1 BOTTLE, WITH APPLICATOR; 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	08/20/2018

Labeler - KOBAYASHI Healthcare International, Inc. (156391729)