Label: ACHELON LIDOCAINE PATCH- lidocaine patch 4% patch
- NDC Code(s): 84209-400-03
- Packager: Achelon, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 26, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredients
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- If pregnant or breastfeeding
- Keep out of reach of children and pets
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Directions
Adults and children 2 years of age or older:
- Apply the patch to clean, dry skin 60 minutes prior to procedure
- Immediately prior to procedure, remove the center of the patch, leaving ring in place to outline treated area
- Follow usual needle procedure steps
- Remove ring after procedure
Children under 2 years of age:
Consult a doctor prior to use
- Box and Drug Facts Panel
-
INGREDIENTS AND APPEARANCE
ACHELON LIDOCAINE PATCH
lidocaine patch 4% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84209-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 7.54 mg in 60.81 cm2 Inactive Ingredients Ingredient Name Strength LEVULINIC ACID (UNII: RYX5QG61EI) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84209-400-03 3 in 1 BOX 03/26/2025 1 20.27 cm2 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 Drug M017 03/25/2025 Labeler - Achelon, Inc (080928345) Registrant - Akron Coating & Adhesives (186569323) Establishment Name Address ID/FEI Business Operations Akron Coating & Adhesives 186569323 manufacture(84209-400)