Label: LIDOCAINE ointment
- NDC Code(s): 80175-0008-5
- Packager: Central Packaging
- This is a repackaged label.
- Source NDC Code(s): 52565-008
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 23, 2021
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INDICATIONS & USAGE
Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx.It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine Ointment USP, 5%.
Frame Style Transparent Dressing are contraindicated as a primary dressing on moderately to heavily draining wounds. Avoid repeated applications on patients with thin or fragile skin that may result in skin damage.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80175-0008(NDC:52565-008) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80175-0008-5 50 g in 1 JAR; Type 0: Not a Combination Product 02/27/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205318 02/27/2017 Labeler - Central Packaging (117617671) Registrant - Central Packaging, LLC (117617671) Establishment Name Address ID/FEI Business Operations Central Packaging, LLC 117617671 relabel(80175-0008)