MENTHOL by SUNSET PAIN RELIEF ROLL-ON 3OZ MENTHOL gel

MENTHOL by

Drug Labeling and Warnings

MENTHOL by is a Otc medication manufactured, distributed, or labeled by SUNSET PAIN RELIEF ROLL-ON 3OZ. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 4%

PURPOSE

Topical Analgesic

USE

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS

For external use only. · Ask a doctor before use if you have redness over affected area

WHEN USING

Use only as directed.
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken or irritated skin.
If you experience an allergic reaction, discontinue use and consult a doctor.

Do not expose the area treated with product to heat or direct sunlight.

STOP USE

Stop use and ask a doctor if

Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help, or contact a Poison Control Center right away.

DIRECTIONS

Adults and Children over 12 years

Apply a small amount to the affected area.
Massage in circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a doctor.

OTHER SAFETY INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

INACTIVE INGREDIENT

Water (Aqua), Alcohol Denat, Glycerin, Ceteareth-25, Caprylic/Capric Triglyceride, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Cannabidiol, Methyl Salicylate.

SUNSET PAIN RELIEF +350 CBD ROLL-ON

INGREDIENTS AND APPEARANCE

MENTHOL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CANNABIDIOL (UNII: 19GBJ60SN5)
SALICYLIC ACID (UNII: O414PZ4LPZ)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
SORBIC ACID (UNII: X045WJ989B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-004-03	90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/24/2019

Labeler - SUNSET PAIN RELIEF ROLL-ON 3OZ (067218145)