BENE PATCH - lidocaine hcl, menthol patch 
Zhejiang Bangli Medical Products Co., Ltd

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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Drug Facts

ACTIVE INGREDIENTS:

Lidocaine HCL  4.00 %

Menthol  1.00 %


Lidocaine HCL 4.00 %     Topical Analgesic

Menthol   1.00 %             External Analgesic

USES:

For temporary relief 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.
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not bandage tightly.
  • If pregnant or breast feeding, contact physician before 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 a 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, Camelia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin,

Glycerin, Isopropyl Myristate, PEG - 8, Phenoxyethanol, Polysorbate - 80, Sodium Lauryl Sulfate,

Triethanolamine, FD C Blue No. 1, FD C Yellow No. 5.

Store below 25 degrees

Avoid direct sunlight.

copy of label

BENE PATCH  
lidocaine hcl, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57900-008
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) LIDOCAINE4 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57900-008-0115 in 1 BOX03/15/201509/01/2016
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 finalpart34803/15/201509/01/2016
Labeler - Zhejiang Bangli Medical Products Co., Ltd (421295875)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products Co., Ltd421295875manufacture(57900-008)

Revised: 9/2016
 
Zhejiang Bangli Medical Products Co., Ltd