Menthozen Cream

Menthozen Cream

Drug Labeling and Warnings

Drug Details

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MENTHOZEN- methyl salicylate, menthol, capsaicin cream 
Proficient Rx LP

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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Menthozen Cream

DRUG FACTS:

ACTIVE INGREDIENTS:

Methyl Salicylate 20.00%

Menthol 5.00%

Capsaicin 0.0375%

Topical Analgesic

USES:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

WARNINGS:

  • For external use only.
  • Avoid contact with the eyes.
  • If condition worsens, or if symptoms persist for more than seven days or clear up and occur again with a few days, discontinue use of this product and consult a physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

contact a physician prior to use.

DIRECTIONS:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

OTHER INFORMATION:

Store at room temperature.

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, DMDM Hydantoin, Emulsifying Wax, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

71205-153-72
MENTHOZEN 
methyl salicylate, menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71205-153(NDC: 71574-600)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.375 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71205-153-721 in 1 BOX11/01/2018
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2018
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079502574RELABEL(71205-153)

Revised: 12/2018
 
Proficient Rx LP


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