Label: PAIN RELIEVING PATCH- lidocaine 4% patch
- NDC Code(s): 84273-001-01
- Packager: Hunan En Pu Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 26, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
-
WHEN USING
use only as directed. Read and follow all directions and warnings on this carton.
do not allow contact with the eyes
heat (such as heating pads) to the area of use
do not use at the same time as other topical analgesics
dispose of used patch in manner that always keeps product away from children and pets.
Used patches stll contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Adults and children 12 years of age and older:
Wash and dry the affected area.
Peel off the backing film from one side of the patch carefully
Apply the exposed portion of the patch to the affected area.
Gently press the patch with your hand to fit the affected area completely.
Do not exercise vigorously during use to prevent the patch from falling off.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEVING PATCH
lidocaine 4% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84273-001 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 Inactive Ingredients Ingredient Name Strength TARTARIC ACID (UNII: W4888I119H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYVINYL ALCOHOL (18000 MW) (UNII: BRY146A46V) ALCOHOL (UNII: 3K9958V90M) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) GLYCERIN (UNII: PDC6A3C0OX) METHYL ACRYLATE (UNII: WC487PR91H) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84273-001-01 5 in 1 BOX 04/22/2024 1 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 04/22/2024 Labeler - Hunan En Pu Pharmaceutical Co., Ltd. (842391330) Establishment Name Address ID/FEI Business Operations Hunan En Pu Pharmaceutical Co., Ltd. 842391330 manufacture(84273-001)