Label: LIDOCAINE PAIN RELIEF GEL-PATCH- lidocaine patch
- NDC Code(s): 83602-158-01, 83602-158-18
- Packager: Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.
- 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 August 5, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use ... if
- ... ask a doctor if
- If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
-
Directions
Adults and Children above 12 years old:
- Clean and dry the affected area.
- Tear off the proctive film and apply the exposed part of the patch to the affected area.
- Carefully remove remaining film while pressing the patch firmly on the skin.
- Remove patch from the skin after at most 8-hour application.
Children under age of 12: Consult a doctor
- Inactive Ingredients
- Usage
- Questions or Comments
- Package label. Principal display panel
-
INGREDIENTS AND APPEARANCE
LIDOCAINE PAIN RELIEF GEL-PATCH
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83602-158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE K90 (UNII: RDH86HJV5Z) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) KAOLIN (UNII: 24H4NWX5CO) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83602-158-18 18 in 1 BOX 08/08/2023 1 NDC:83602-158-01 12 g 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 not final part348 08/08/2023 Labeler - Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. (418399704) Registrant - Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. (418399704) Establishment Name Address ID/FEI Business Operations Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 546872672 manufacture(83602-158) , label(83602-158)