LIDOCAINE 5 PERCENT- lidocaine cream 
Alexso, 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 5_Percent Cream

LIDOCAINE - Lidocaine 5% anorectal cream
Alexso, 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 5% Anorectal Cream

​Drug Facts

Active ingredient

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

For the temporary relief of local pain, soreness, burning, itching or discomfort associated with anorectal disorders.

Warnings

​For external use only.

When using this product

  • avoid contact with eyes
  • do not exceed recommended daily dosage unless directed by a physician
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • in case of bleeding, consult a physician promptly

Stop use and ask a physician if

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
  • if pregnant or breastfeeding

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Consult a physician.

Other information

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Juice), Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativus (Hemp) Seed Oil, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Yerba Mate) Extract, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Magnesium Sulfate, Phenoxyethanol, Polyacrylamide, Stearic Acid. 

PRINCIPAL DISPLAY PANEL

Lidocaine 5% Cream

NDC 50488-6265-1

​Lidocaine 5% 

Anorectal Cream

Topical Anesthetic

50 grams

Manufactured for: 

Alexso, Inc. 

Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL
Lidocaine 5% Cream
NDC 50488-6265-1
Lidocaine 5% 
Anorectal Cream
Topical Anesthetic
50 grams


Manufactured for: 
Alexso, Inc. 
Los Angeles, CA 90064

LIDOCAINE 5 PERCENT 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-6265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURETH-7 (UNII: Z95S6G8201)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50488-6265-11 in 1 CARTON07/01/2020
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34607/01/2020
Labeler - Alexso, Inc (963338061)

Revised: 7/2020
Document Id: 63bbefb5-cc08-407d-ba61-a01955afefe8
Set id: 3953ccf4-f772-4f9c-ae7e-f373b6fe16dd
Version: 1
Effective Time: 20200703
 
Alexso, Inc