DZUL ARTHRITIS PAIN RELIEF- menthol cream 
Caball Sales, Inc.

----------

83037-015-04

Menthol 1.5%

Topical Analgesic

USE

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

•For external use only.

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

Avoid contact with the eyes or mucous membranes.
Do not apply to wounds or damaged skin.
Do not apply to the irritated skin or if excessive irritation develops.
Do not bandage tightly.
Do not use with heating pad or device.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

If pregnant or breast – feeding

Ask a health professional before use.

If swallowed, get medical help, or contact a Poison Control Center right away.

DIRECTIONS

Adults and Children over 12 years

Apply a small amount on the affected area.
Massage in circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: Do not use, consult a doctor.

OTHER INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59-86 F (15°-30° C).

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Eucalyptus Globulus Leaf Oil, Glycereth-26, Polysorbate 60, Methylsulfonylmethane (MSM), Sodium Chondroitin Sulfate, Glucosamine Sulfate, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, Polysorbate 20, Caprylyl Glycol, Sodium Hydroxide, Phenoxyethanol, Hexylene Glycol.

DZUL ARTHRITIS PAIN RELIEF CREAM

ARTHRITIS

DZUL ARTHRITIS PAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83037-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALCOHOL (UNII: 3K9958V90M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERETH-26 (UNII: NNE56F2N14)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
HYDROXYPROLINE (UNII: RMB44WO89X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83037-015-04114 g in 1 JAR; Type 0: Not a Combination Product04/20/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/20/2024
Labeler - Caball Sales, Inc. (047422138)

Revised: 4/2024
Document Id: 159c301c-d463-bb2c-e063-6394a90a9e5a
Set id: 159c301c-d462-bb2c-e063-6394a90a9e5a
Version: 1
Effective Time: 20240408
 
Caball Sales, Inc.