Label: LIDOCAINE HYDROCHLORIDE liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51532-6101-2 - Packager: Afassco 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 July 31, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL – 2 oz. bottle
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INGREDIENTS AND APPEARANCE
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-6101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride 200 mL in 1 L Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) propylene glycol (UNII: 6DC9Q167V3) diazolidinyl urea (UNII: H5RIZ3MPW4) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-6101-2 0.059 L in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/16/2012 Labeler - Afassco Inc. (609982723) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(51532-6101)