Label: LIDOCAINE PATCH- lidocaine 4% menthol 1% patch
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Contains inactivated NDC Code(s)
NDC Code(s): 73317-6863-5 - Packager: SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
- 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 5, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
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Dosage and Administration
Directions: Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Discard patch after single use. Do not expose area to heat.
Children under 12 years of age: Consult a physician.
- Warnings
- Do not use
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When using this product
■ do not allow contact with the eyes
■ use only as directed, read and follow all directions and warnings on this package
■ do not bandage tightly or apply local heat
■ 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 reuse patch
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children and pets.
- Other Safety Information
- Inactive Ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE PATCH
lidocaine 4% menthol 1% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73317-6863 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P) HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73317-6863-5 15 in 1 CARTON 07/02/2021 1 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 07/02/2021 Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
