OTC Medication Information: Lidocaine 5 Percent

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.

LIDOCAINE — L idocaine 5 % anorectal c ream
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.

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 % C ream

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
(click image for full-size original)
LIDOCAINE 5 PERCENT
lidocaine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-6265
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
WATER
ARNICA MONTANA FLOWER
INDIAN FRANKINCENSE
CANNABIS SATIVA SEED OIL
ETHYLHEXYLGLYCERIN
GLYCERYL MONOSTEARATE
GLYCYRRHIZA GLABRA
SUNFLOWER OIL
C13-14 ISOPARAFFIN
ISOPROPYL MYRISTATE
LAURETH-7
MAGNESIUM SULFATE, UNSPECIFIED
PHENOXYETHANOL
STEARIC ACID
ILEX PARAGUARIENSIS LEAF
POLYACRYLAMIDE (10000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50488-6265-1 1 TUBE in 1 CARTON contains a TUBE
1 50 g in 1 TUBE This package is contained within the CARTON (50488-6265-1)
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)

Revised: 07/2020 Alexso, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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