PROPLEX LIDOCAINE- lidocaine cream 
Natureplex LLC

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.

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PROPLEX LIDOCAINE 4%

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Topical analgesic

Use

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Warnings

For external use only.

Avoid contact with eyes.

Not for prolonged use.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • rash or irritation develops, persists, or increases

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Adults and children 2 years of age and older:

Children under 2 years of age:

Other information

Inactive ingredients

Aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

NDC # 67234-052-01

lidocaine
4%

NET WT. 3 oz (85 g)

PROPLEX

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PROPLEX LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-052-011 in 1 CARTON03/18/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/18/2019
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-052)

Revised: 1/2021
Document Id: de9e7c69-0842-4eb5-af1d-41f259b39571
Set id: 9975050c-8a84-4265-960f-a13729922764
Version: 2
Effective Time: 20210112
 
Natureplex LLC