Lidocaine 5_percent Cream

Lidocaine 5_percent Cream
SPL v1
SPL
SPL Set ID 3953ccf4-f772-4f9c-ae7e-f373b6fe16dd
Route
TOPICAL
Published
Effective Date 2020-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
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)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-07-01

Description

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

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

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

Uses

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

Section 42229-5

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

Warnings

​For external use only.

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.

Active Ingredient

Lidocaine 5% w/w

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.
Stop Use and Ask A
  • 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
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

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
Keep Out of Reach of Children.

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

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

Purpose

Topical anesthetic

Warnings

​For external use only.

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.

Active Ingredient (Active ingredient)

Lidocaine 5% w/w

Other Information (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.
Stop Use and Ask A (Stop use and ask a)
  • 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
Inactive Ingredients (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 (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

When Using This Product (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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


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Raw Label Data

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