Label: CURIST LIDOCAINE PATCH MAXIMUM STRENGTH- lidocaine patch
- NDC Code(s): 72559-025-19
- Packager: Little Pharma, Inc.
- 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 4, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Do not use
- on raw surfaces, blistered areas, wounds or other damaged skin
- with a heating pad
- more than one patch on your body at a time
- with other topical anagesics
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DOSAGE & ADMINISTRATION
Directions
- adults and children 12 years of age and older:
- clean and dry the affected area
- open pouch and remove one patch
- remove the protective backing from the patch starting at the corner
- apply sticky side of patch to affected area
- reseal pouch containing unused patches after each use
- use one patch for up to 12 hours
- discard patch after single use
- children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CURIST LIDOCAINE PATCH MAXIMUM STRENGTH
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72559-025 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 BLACK PEPPER (UNII: KM66971LVF) ACRYLIC ACID (UNII: J94PBK7X8S) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72559-025-19 20 in 1 POUCH 08/04/2022 1 2.5 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 08/04/2021 Labeler - Little Pharma, Inc. (074328189)