LIDOCAINE 5 PERCENT- lidocaine cream

Lidocaine 5 Percent by

Drug Labeling and Warnings

Lidocaine 5 Percent by is a Otc medication manufactured, distributed, or labeled by Alexso, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• May be applied under occlusive dressing.
  
• Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

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

INGREDIENTS AND APPEARANCE

LIDOCAINE 5 PERCENT 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-6265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-6265-1	1 in 1 CARTON	07/01/2020
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	07/01/2020

Labeler - Alexso, Inc (963338061)