BRAZILIAN MENTHOL PAIN RELIEVING ROLL ON- menthol cream 
DDR Product, LLC

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BRAZILIAN MENTHOL Pain Relieving Roll-On

DRUG FACTS:

Active Ingredient:

Menthol 10.00% 

Topical Analgesic

Indications:

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

Warnings:

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 physician prior to use.

Directions:

Additional Information:

Store at room temperature.

Other Ingredients:

Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Ascorbic Acid (Vitamin C), Boswellia Serrata Extract, Carbomer, Magnesium Sulfate, Methylisothiazolinone, Methylsulfonylmethane (MSM), Polysorbate-20, SD-Alcohol 40B, Triethanolamine.

Package Labeling:

Label

BRAZILIAN MENTHOL PAIN RELIEVING ROLL ON 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71977-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71977-125-0488.72 mL in 1 BOTTLE; Type 0: Not a Combination Product12/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/27/2017
Labeler - DDR Product, LLC (080781689)

Revised: 11/2023
Document Id: 09dc19d0-24c9-bd12-e063-6294a90ab40f
Set id: 6f01c159-5a1e-4db8-aad0-7c01e8171c1a
Version: 4
Effective Time: 20231111
 
DDR Product, LLC