Label: LIDALL- lidocaine patch
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Contains inactivated NDC Code(s)
NDC Code(s): 64533-000-01 - Packager: MedVantage Pharmaceutical, 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 April 29, 2014
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- Official Label (Printer Friendly)
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Warnings
For external use only
Do not use
■ other than directed
■ on wounds
■ on damaged skin
■if you are allergic to menthol
■ in large quantities, particularly over raw services or blistered areas
When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
Stop use and ask a doctor
■ excessive irritation of the skin develops
■ condition worsens
■symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
- Active ingredients
- Inactive ingredients
- KEEP OUT OF REACH OF CHILDREN
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Directions
Directions
■Clean and dry affected area. Cut open pouch and remove patch.
■Remove protective film and apply directly to affected area.
■Wash hands with soap after applying patch.
■Reseal pouch containing unused patches.
■Adults and children 12 years of age and older: Apply to affected area; change patch 1 to 2 times daily. Do not apply
to affected are more than 3 times daily.
■Children under 12 years of age: Consult a physician before use.
- Purpose
- Use
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDALL
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64533-000 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 MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETIC ACID (UNII: 9G34HU7RV0) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64533-000-01 100 g in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2013 Labeler - MedVantage Pharmaceutical, LLC (079094932) Registrant - MedVantage Pharmaceutical, LLC (079094932) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(64533-000)
