BRAZILIAN MENTHOL Pain Relieving Roll On

Manufacturer: DDR Product, LLC
Effective date: 2024-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 20:46:22

Label at a glance#

ProductBRAZILIAN MENTHOL Pain Relieving Roll On

Active ingredientMENTHOL

Label structure7 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.00%

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.
Do not apply to wounds or damaged skin.
Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

BRAZILIAN MENTHOL Pain Relieving Roll On
MENTHOL
ALOE VERA LEAF
WATER
ARNICA MONTANA
ASCORBIC ACID
INDIAN FRANKINCENSE
CARBOXYPOLYMETHYLENE
MAGNESIUM SULFATE, UNSPECIFIED FORM
METHYLISOTHIAZOLINONE
DIMETHYL SULFONE
POLYSORBATE 20
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71977-125	71977-125-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
ARNICA MONTANA	O80TY208ZW	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
INDIAN FRANKINCENSE	4PW41QCO2M	IACT
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
MAGNESIUM SULFATE, UNSPECIFIED FORM	DE08037SAB	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
TROLAMINE	9O3K93S3TK	IACT
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2922b02c-3598-e15b-e063-6394a90afecf			6f01c159-5a1e-4db8-aad0-7c01e8171c1a	2024-12-13	Warnings	Exact identifier spl id: 2922b02c-3598-e15b-e063-6394a90afecf spl set id: 6f01c159-5a1e-4db8-aad0-7c01e8171c1a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.