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NDC 71977-0010-03 DAREDEVIL STRENGTH Muscle and Arthritis Pain Relieving Roll On 100 mg/mL Details

DAREDEVIL STRENGTH Muscle and Arthritis Pain Relieving Roll On 100 mg/mL

DAREDEVIL STRENGTH Muscle and Arthritis Pain Relieving Roll On is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by DDR Products, LLC. The primary component is MENTHOL.

Product Information

NDC	71977-0010
Product ID	71977-010_7bd502be-7d92-62c8-e053-2a91aa0ab630
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DAREDEVIL STRENGTH Muscle and Arthritis Pain Relieving Roll On
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	DDR Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71977-0010-03 (71977001003)

Pricing Information	N/A
NDC Package Code	71977-010-03
Billing NDC	71977001003
Package	88.72 mL in 1 CONTAINER (71977-010-03)
Marketing Start Date	2018-10-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2764574f-381f-41e6-85d7-d8f3ce474075 Details

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

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:71977-010-03	88.72 mL in 1 CONTAINER; 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 not final	part348	10/25/2018

Labeler - DDR Products, LLC (080781689)

Revised: 11/2018

Document Id: 7bd502be-7d92-62c8-e053-2a91aa0ab630

Set id: 2764574f-381f-41e6-85d7-d8f3ce474075

Version: 3

Effective Time: 20181129