Label: ODYNIA-R REGULAR- lidocaine, menthol patch
-
Contains inactivated NDC Code(s)
NDC Code(s): 69647-001-01 - Packager: Ursh Pharmaceutical Inc.
- 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 May 14, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)
