DAREDEVIL STRENGTH MUSCLE AND ARTHRITIS PAIN RELIEVING ROLL ON- menthol gel

DAREDEVIL STRENGTH Muscle and Arthritis Pain Relieving Roll On by

Drug Labeling and Warnings

DAREDEVIL STRENGTH Muscle and Arthritis Pain Relieving Roll On by is a Otc medication manufactured, distributed, or labeled by DDR Products, 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 od 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), Carbomer, Glycerin, Magnesium Sulfate, Phenoxyethanol, SD-Alcohol 40B, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

DAREDEVIL STRENGTH MUSCLE AND ARTHRITIS PAIN RELIEVING ROLL ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71977-010
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)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71977-010-03	88.72 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/25/2018

Labeler - DDR Products, LLC (080781689)