Label: PROPLEX LIDOCAINE- lidocaine cream
- NDC Code(s): 67234-052-01
- Packager: Natureplex 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 January 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
-
INGREDIENTS AND APPEARANCE
PROPLEX LIDOCAINE
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-052 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 Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARGININE (UNII: 94ZLA3W45F) SULISOBENZONE (UNII: 1W6L629B4K) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) ANGOPHORA COSTATA WHOLE (UNII: O5MY197D8F) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) WATER (UNII: 059QF0KO0R) JOJOBA OIL (UNII: 724GKU717M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) STEARIC ACID (UNII: 4ELV7Z65AP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-052-01 1 in 1 CARTON 03/18/2019 1 85 g in 1 TUBE; 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 03/18/2019 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-052)