Label: TOPCARE PAIN RELIEF PATCHES- lidocaine patch
- NDC Code(s): 36800-156-05, 36800-156-06
- Packager: TOPCO ASSOCIATES, LLC
- 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 January 11, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Dosage and Administration
Directions Adults and children over 12 years:
■ clean and dry affected area
■ 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
■ use one patch for up to 12 hours. Children under 12 years of age: consult a physician.
- Warnings
- Idications and Usage
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When using this product
■ use only as directed
■ read and follow all directions and warnings on this carton
■ do not allow contact with the eyes
■ do not use at the same time as other topical analgesics
■ do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ do not microwave
■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
- Stop use and consult a doctor
- PREGNANCY OR BREAST FEEDING
- Do not Use
- Keep out of reach of children and pets.
- Other Safety Information
- Inactive Ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPCARE PAIN RELIEF PATCHES
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-156 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 Inactive Ingredients Ingredient Name Strength ALUMINUM (UNII: CPD4NFA903) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-156-05 5 in 1 CARTON 07/01/2017 1 9 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:36800-156-06 6 in 1 CARTON 09/01/2021 2 9 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 07/01/2017 Labeler - TOPCO ASSOCIATES, LLC (006935977) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co.,Ltd. 529128763 manufacture(36800-156)
