DAREDEVIL STRENGTH MUSCLE AND ARTHRITIS PAIN RELIEVING- menthol gel
DDR Products, LLC

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DAREDEVIL STRENGTH Muscle & Arthritis Pain Relieving Gel

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.

DAREDEVIL STRENGTH Muscle & Arthritis Pain Relieving Gel

Label2

DAREDEVIL STRENGTH Muscle & Arthritis Pain Relieving Gel

Label3

DAREDEVIL STRENGTH MUSCLE AND ARTHRITIS PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71977-011
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71977-011-04	118.29 mL in 1 JAR; Type 0: Not a Combination Product	10/25/2018	12/30/2020
2	NDC:71977-011-05	5 mL in 1 PACKET; Type 0: Not a Combination Product	10/25/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/25/2018	12/30/2020

Labeler - DDR Products, LLC (080781689)

Revised: 10/2023

Document Id: 07214a2e-8ddf-66b5-e063-6294a90a27a7

Set id: 9a8e0e3d-b56b-420a-ae7c-cc53460ef1ec

Version: 3

Effective Time: 20231007

DDR Products, LLC