BRAZILIAN MENTHOL PAIN RELIEVING- menthol cream 
DDR Product, LLC

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BRAZILIAN MENTHOL Pain Relieving

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:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Ascorbic Acid (Vitamin C), Boswellia Serrata  Extract, Cetearyl Olivate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, SD-Alcohol 40B, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

Label2

BRAZILIAN MENTHOL PAIN RELIEVING 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71977-126
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)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CORN (UNII: 0N8672707O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71977-126-041 in 1 BOX12/27/2017
1118.294 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/27/2017
Labeler - DDR Product, LLC (080781689)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(71977-126)

Revised: 11/2023
Document Id: 09dc14d7-b6bc-1a86-e063-6394a90a0122
Set id: b75eaee2-1233-4dcb-ac90-7c4b10bd4ace
Version: 3
Effective Time: 20231111
 
DDR Product, LLC