Label: LIDOCAINE PATCH- lidocaine hci 4% patch
- NDC Code(s): 81484-501-01, 81484-501-02
- Packager: Anhui Miao De Tang Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Adults and children over 12 years:
·Wash and dry the affected areaRemove backing from patch by firmty grasping both ends and gently pulling until backing separates in the middle
· Carefully remove smaller portion of back,ng from patch and apply exposed portion of patch to aected areaOnce exposed portion of· patch is pooned.carefully remove remaining backing tocomplelely apply patch to afected areaCarefully remove smaller portion of
· backing from patch and apply exposed portion of patch to affected area
· Use only 1 patch for a maximum of 24 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIDOCAINE PATCH
lidocaine hci 4% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81484-501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.4 g Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYLPARABEN (UNII: A2I8C7HI9T) TARTARIC ACID (UNII: W4888I119H) CARBOXYMETHYLCELLULOSE SODIUM (0.9 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 130 MPA.S AT 4%) (UNII: 0891BL4S3D) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CASTOR OIL (UNII: D5340Y2I9G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) RACEMENTHOL (UNII: YS08XHA860) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81484-501-02 30 in 1 BOX 03/14/2023 1 NDC:81484-501-01 1 in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 03/14/2023 Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102) Establishment Name Address ID/FEI Business Operations Anhui Miao De Tang Pharmaceutical Co., Ltd. 405744102 manufacture(81484-501)
