VENIA PATCH PREMIUM PAIN PATCH- menthol, lidocaine patch

Venia Patch by

Drug Labeling and Warnings

Venia Patch by is a Otc medication manufactured, distributed, or labeled by Alivio Medical Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Menthol 4 %

Lidocaine 4 %

PURPOSE

Purpose

Topical anesthetic

Topical anesthetic

INDICATIONS & USAGE

Uses:

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

backache, strains, muscle soreness and stiffness

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VENIA PATCH  PREMIUM PAIN PATCH
menthol, lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69512-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4 mg  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69512-700-05	10 in 1 BOX
1		1 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	08/01/2015

Labeler - Alivio Medical Products, LLC (079670828)