BRAZILIAN MENTHOL PAIN RELIEVING ROLL ON- menthol cream

BRAZILIAN MENTHOL Pain Relieving Roll On by

Drug Labeling and Warnings

BRAZILIAN MENTHOL Pain Relieving Roll On by is a Otc medication manufactured, distributed, or labeled by DDR Product, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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:

INGREDIENTS AND APPEARANCE

BRAZILIAN MENTHOL PAIN RELIEVING ROLL ON 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71977-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71977-125-04	88.72 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2017

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)