LIDOCAINE- lidocaine cream 
Advanced Rx Pharmacy of Tennessee, 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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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

How Supplied/Storage and Handling

Lidocaine 4% Cream is supplied in:

15g tube NDC: 80425-0351-01

Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

label 1

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0351(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:80425-0351-11 in 1 CARTON07/31/2023
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/31/2023
Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0351)

Revised: 7/2023
Document Id: 01cb11bb-72ff-d044-e063-6394a90a5e15
Set id: 01cb19a4-ce22-144d-e063-6294a90a8aa3
Version: 1
Effective Time: 20230731
 
Advanced Rx Pharmacy of Tennessee, LLC