BENEPATCH- lidocaine hydrochloride, menthol patch 
Meds Direct Rx, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BenePatch (69418-002)

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%
Menthol 1.00%

Topical Anesthetic
External Analgesic

USES:

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

WARNINGS:

Keep out of reach of children.

If swallowed, consult physician.

DIRECTIONS:

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)

Front

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BENEPATCH 
lidocaine hydrochloride, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69418-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeRECTANGLE (patch) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69418-002-013 in 1 BOX
15 in 1 POUCH
115 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/24/2015
Labeler - Meds Direct Rx, Inc. (064053428)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co. Ltd529128763manufacture(69418-002)

Revised: 11/2015
Document Id: 24d86c23-664b-00dc-e054-00144ff8d46c
Set id: 0ce3c764-b905-418a-e054-00144ff8d46c
Version: 11
Effective Time: 20151118
 
Meds Direct Rx, Inc.