ZIMS MAX FREEZE LEG CRAMP- menthol 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., KOBAYASHI America Manufacturing, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Camphor 3.1%	Topical analgesic
Menthol 5%	Topical analgesic
Methyl Salicylate 11.5%	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

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
• after expiration date

When using this product

• to avoid excess application, press applicator gently against skin
• do not bandage tightly or cover with wrap or use heating pad or TENS device
• do not use 1 hour prior to bathing or within 30 minutes after bathing
• do not use other 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, burning sensation, swelling or blistering of the skin develops
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

If you are pregnant or breastfeeding, 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 immediately.

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

• allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use
• store in a cool place away from direct sunlight
• store with cap closed tightly

Inactive ingredients

Dimethyl Isosorbide, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Tocopheryl Acetate, Water, Zingiber Officinale (Ginger) Root Extract.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton

ZIM'S™
MAX-
FREEZE

For Minor Pain Caused by
LEG CRAMPS

Relax & Relieve
Muscles

Fast Acting
Liquid

Easy to Use
Angled Bottle

Pain Relieving
Liquid
3 fl oz (89mL)

3 POWERFUL INGREDIENTS

INGREDIENTS AND APPEARANCE

ZIMS MAX FREEZE   LEG CRAMP
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54273-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	31 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	50 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	115 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54273-011-01	1 in 1 CARTON	09/01/2022
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 drug	M017	09/01/2022

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(54273-011) , LABEL(54273-011)