VENIA PATCH PREMIUM PAIN PATCH- menthol, lidocaine 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

Menthol 4 %

Lidocaine 4 %

Purpose

Topical anesthetic

Topical anesthetic

Uses:

For the temporary relief of minor aches and muscle pains associated with arthritis, simple

backache, strains, muscle soreness and stiffness

Warnings:

-Only for external use. Use only as directed or by a health professional.

-Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth,

genitals, or any other mucous membranes.

-Do not cover with bandage.

-Keep out of reach of children.Consult physician for children under 12.

-Consult your physician: if pregnant or pain persists or worsens.

Directions:

-Adults and children 12 years and over. Apply patch to affected area 1 to 2 times daily or

as directed.

-Instructions for use:

-Clear and dry the affected area

-Open pouch and remove one patch

-Remove any protective film and apply directly to affected area of pain

-Wash hands with soap and water after applying patch

-Reseal pouch containing unused patches after each use

Keep out of reach of children. Consult physician for children under 12

Other ingredients:

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2 Ethylhexyl Acrylate, Glycerin, Isopropyl

Myristate, Methyl Acrylate, Nonoxynol 30, Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan

Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water

copy of label

VENIA PATCH  PREMIUM PAIN PATCH
menthol, lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57900-700
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 mg  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57900-700-0510 in 1 BOX08/01/201509/01/2016
11 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 finalpart34808/01/201509/01/2016
Labeler - Zhejiang Bangli Medical Products Co., Ltd (421295875)

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