BRAZILIAN MENTHOL Pain Relieving

Dosage form: cream
Ingredients: MENTHOL 100mg in 1mL
Labeler: DDR Product, LLC
NDC code: 71977-126

Medically reviewed by Drugs.com. Last updated on Dec 18, 2023.

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:

For external use only.
Avoid contact with eyes.
If symptoms persist for more than seven days, discontinue use and consult 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 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.

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:

BRAZILIAN MENTHOL PAIN RELIEVING
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71977-126
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	100 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
WATER
ARNICA MONTANA
ASCORBIC ACID
INDIAN FRANKINCENSE
CETEARYL OLIVATE
ETHYLHEXYLGLYCERIN
GLYCERIN
GLYCERYL MONOSTEARATE
HELIANTHUS ANNUUS FLOWERING TOP
MAGNESIUM SULFATE, UNSPECIFIED FORM
DIMETHYL SULFONE
PHENOXYETHANOL
SORBITAN OLIVATE
.ALPHA.-TOCOPHEROL
XANTHAN GUM
CORN

Packaging
#	Item Code	Package Description
1	NDC:71977-126-04	1 JAR in 1 BOX
1		118.294 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/27/2017

Labeler - DDR Product, LLC (080781689)

Establishment
Name	Address	ID/FEI	Operations
Pure Source, LLC		080354456	manufacture(71977-126)

Revised: 12/2017

Document Id: 6154b58e-d1dc-9114-e053-2991aa0a38ae

Set id: b75eaee2-1233-4dcb-ac90-7c4b10bd4ace

Version: 2

Effective Time: 20171227

DDR Product, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer