Label: POINT RELIEF LIDOSPOT- lidocaine, menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 51452-173-01, 51452-173-05 - Packager: Fabrication Enterprises
- 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 April 5, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purposes
- Uses
- Warnings
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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 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.
- Do not use
- Stop use and consult a doctor if
- If pregnant or breastfeeding,
- Keep out of reach of children and pets
- Directions
- Inactive ingredients
- Other information
- Package label. Principal display panel
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INGREDIENTS AND APPEARANCE
POINT RELIEF LIDOSPOT
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51452-173 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.03 g in 3 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.12 g in 3 g Inactive Ingredients Ingredient Name Strength KAOLIN (UNII: 24H4NWX5CO) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) POVIDONE K90 (UNII: RDH86HJV5Z) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51452-173-05 5 in 1 POUCH 04/05/2022 1 NDC:51452-173-01 3 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 04/05/2022 Labeler - Fabrication Enterprises (070577218) Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672) Establishment Name Address ID/FEI Business Operations Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 546872672 manufacture(51452-173)