LIDOCAINE- lidocaine cream 
Patrin Pharma Inc.

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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Lidocaine Cream 4%

Drug Facts

Active Ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to

Directions

Warnings

For external use only.

Do not use

  • in or near the eyes
  • in large quantities, particularly over raw or blistered areas

Stop use and ask a doctor if

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

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

Other Information

Inactive ingredients

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.

Questions?

Call 800-936-3088

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

NDC 39328 - 024 - 30

Lidocaine 4%
Topical Anesthetic Cream
FOR EXTERNAL USE ONLY

PATRIN
PHARMA

Net Wt. 30 grams

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton
LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Trolamine (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39328-024-555 in 1 CARTON11/01/2018
15 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:39328-024-151 in 1 CARTON11/01/2018
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:39328-024-301 in 1 CARTON11/01/2018
330 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:39328-024-565 in 1 CARTON11/01/2018
45 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34811/01/2018
Labeler - Patrin Pharma Inc. (806841677)

Revised: 4/2022
Document Id: 1c506667-9c89-4467-ac09-d1da6b67fd48
Set id: 91eedf9d-53b8-49d5-af59-25019606a0b2
Version: 2
Effective Time: 20220408
 
Patrin Pharma Inc.