MAXFIT FREEZE- menthol gel 
NeoPharm USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MAXFIT FREEZE

Drug Facts

Active Ingredients

Menthol 5.0%

Purpose

Topical Analgesic

Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings  For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis like conditions

Ask a doctor before use if you have redness over the affected area.

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age or older

apply to affected area not more that 3 to 4 times daily

children under 12 years of age
ask a doctor

Other Information

  • store at 68 - 77 degree Fahrenheit (20 - 25 degrees Celsius)
  • see end of carton or tube crimp for lot number and expiration date

Inactive Ingredients

WATER, ETHANOL, TAURINE, ARNICA MONTANA FLOWER EXTRACT,

PAULLINIA CUPANA SEED EXTRACT, PANTHENOL, NIACINAMIDE,

VISCUM ALBUM (MISTLETOE) FRUIT EXTRACT, TOCOPHERYL

ACETATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER,

SILICA, TRIETHANOLAMINE, CARBOMER, PHENOXYETHANOL,

BIOTINOYL HEXAPEPTIDE-2 AMIDE

Distributed by: NeoPharm USA, 1 Oyster Bay Drive,

Rumson, NJ 07760

Made in Korea

image descriptionimage description

MAXFIT FREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
TAURINE (UNII: 1EQV5MLY3D)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
PANTHENOL (UNII: WV9CM0O67Z)  
NIACINAMIDE (UNII: 25X51I8RD4)  
VISCUM ALBUM FRUIT (UNII: P83EQ521R3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0700-01 in 1 CARTON08/12/201409/01/2016
170 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/12/201409/01/2016
Labeler - NeoPharm USA (965502912)

Revised: 9/2016
Document Id: 3b7743da-597a-6b5f-e054-00144ff88e88
Set id: 5c9910c1-f4b4-4041-a2e5-6c4df1e198b8
Version: 3
Effective Time: 20160901
 
NeoPharm USA