Label: MAXIMUM STRENGTH LIDOCAINE PATCH- lidocaine patch
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Contains inactivated NDC Code(s)
NDC Code(s): 76168-308-13 - Packager: Velocity Pharma 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 July 19, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
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When Using This Product
- use only as directed. Read and follow all directions and warnings on this label.
- do not allow contact with the eyes
- do not bandage tightly or apply local 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 or 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 Ask a Doctor if
- If Pregnant or Breast Feeding
- Keep Out of Reach of Children and Pets
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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 1 patch for up to 12 hours
children 12 years or younger: ask a doctor
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH LIDOCAINE PATCH
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-308 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg Inactive Ingredients Ingredient Name Strength SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MINERAL OIL (UNII: T5L8T28FGP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) STYRENE (UNII: 44LJ2U959V) POLYBUTESTER (UNII: A68634Y1LL) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-308-13 6 in 1 CARTON 05/26/2017 1 1 in 1 POUCH; 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 05/26/2017 Labeler - Velocity Pharma LLC (962198409)