ANORECTAL WALGREENS- lidocaine cream 

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 Facts

Active ingredient                               Purpose

Lidocaine 5%......................................Local anesthetic

Uses For temporary relief of pain, soreness and burning.

For external use only

When using this product do not get into eyes.
Stop use and ask a doctor if • condition worsens or does
not improve within 7 days • do not exceed the
recommended daily dosage unless directed by a doctor
• in case of bleeding, consult a doctor promptly • do not put this product into the rectum by using fingers or any mechanical device or applicator

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

Directions Apply externally to affected area up to 6 times daily. Gently dry by patting or blotting with tissue or a soft cloth before application of this product

Other information Store at 25° C (77° F);
excursions permitted to 15-30˚ C (59-86˚ F).

Inactive ingredients
Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

image description

lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Benzyl alcohol (UNII: LKG8494WBH)  
Carbomer 940 (UNII: 4Q93RCW27E)  
Cholesterol (UNII: 97C5T2UQ7J)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Trolamine (UNII: 9O3K93S3TK)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1114-011 in 1 CARTON03/18/2016
128.3 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/18/2016
Labeler - Walgrrens (008965063)
Registrant - Product Quest (927768135)
NameAddressID/FEIBusiness Operations
Product Quest927768135manufacture(0363-1114) , label(0363-1114)

Revised: 10/2017
Document Id: 25cfb264-0ff0-49b8-881a-8c2a40e4134d
Set id: f72e9a3c-a194-4b71-961f-f811b22185e9
Version: 1
Effective Time: 20171010