Label: VENIA PATCH PREMIUM PAIN PATCH- menthol, lidocaine patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69512-700-05 - Packager: Alivio Medical Products, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 19, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VENIA PATCH PREMIUM PAIN PATCH
menthol, lidocaine patchProduct 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)
