Label: NATUREPLEX LIDOCAINE 4%- lidocaine cream
- NDC Code(s): 67234-067-01
- Packager: Natureplex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 11, 2021
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- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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INGREDIENTS AND APPEARANCE
NATUREPLEX LIDOCAINE 4%
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-067 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine 0.04 g in 28 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) SULISOBENZONE (UNII: 1W6L629B4K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Cetyl Alcohol (UNII: 936JST6JCN) Dimethyl Sulfoxide (UNII: YOW8V9698H) Hexylene Glycol (UNII: KEH0A3F75J) TEA TREE OIL (UNII: VIF565UC2G) Phenoxyethanol (UNII: HIE492ZZ3T) Potassium Sorbate (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Stearic Acid (UNII: 4ELV7Z65AP) Arginine (UNII: 94ZLA3W45F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67234-067-01 1 in 1 CARTON 03/15/2017 1 28 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 FINAL part333B 03/15/2017 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-067)