NDC | 69647-001-01 |
Set ID | d829cfab-aa1a-4cf1-be33-06511d3c7c72 |
Category | HUMAN OTC DRUG LABEL |
Packager | Ursh Pharmaceutical Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
adults and children over 12 years:
-remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
-carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
-once exposed portion of patch is positioned, carefully remove remaining backing to completely
apply patch to affected area
-wear one Icy Hot Patch up to 8 hours
-repeat as necessary, but no more than 3 times daily
children under 12 years or younger: ask a doctor
-
INACTIVE INGREDIENT
Inactive ingredients aluminum hydroxide, carmellose sodium, glycerin, isopropyl myristate, methyl
acrylate / 2 -ethylhexyl acrylate copolymer, nonoxynol-30, polyacryic acid, polysorbate 80, sodium polyacrylate, sorbitan
sesquioleate, starch / acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ODYNIA-R REGULAR
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69647-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL ACRYLATE (UNII: WC487PR91H) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ACRYLIC ACID (UNII: J94PBK7X8S) SODIUM (UNII: 9NEZ333N27) SODIUM CHLORIDE (UNII: 451W47IQ8X) 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:69647-001-01 15 in 1 BOX 1 10 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 03/12/2015 Labeler - Ursh Pharmaceutical Inc. (079715344)