BENEPATCH- lidocaine hydrochloride, menthol patch

BenePatch by

Drug Labeling and Warnings

BenePatch by is a Otc medication manufactured, distributed, or labeled by Meds Direct Rx, Inc., Foshan Aqua Gel Biotech Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%
Menthol 1.00%

PURPOSE

Topical Anesthetic
External Analgesic

USES:

For temporary relieft of pain associated with minor cuts, scrapes and minor skin irritations.

WARNINGS:

• For external use only.
• Avoid contact with eyes.
• Do not apply on open wounds or damaged skin.
• If symptoms persist for more than seven days, discontinue use and consult physician.
• Do not bandage tightly.
• If pregnant or breast-feeding, contact physician prior to use.
• Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children.

If swallowed, consult physician.

DIRECTIONS:

• Clean and dry affected area.
• Remove patch from backing and apply to affected area.
• Use only one patch at a time, and maximum of four patches/day.
• Leave patch on affected area for up to 8 hours.
• Do not use patches for longer than 5 consecutive days.
• Children under 12 should consult physician prior to use.

OTHER INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5.

Package Labeling for BenePatch, 15 Count (

69418-002-01)

INGREDIENTS AND APPEARANCE

BENEPATCH 
lidocaine hydrochloride, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69418-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)
ARNICA MONTANA (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape	RECTANGLE (patch)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69418-002-01	3 in 1 BOX
1		5 in 1 POUCH
1		15 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/24/2015

Labeler - Meds Direct Rx, Inc. (064053428)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co. Ltd		529128763	manufacture(69418-002)