NDC | 69512-700-05 |
Set ID | bfe40c92-cdb7-4b61-ab21-a36cf694fd29 |
Category | HUMAN OTC DRUG LABEL |
Packager | Alivio Medical Products, LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
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)