Lidocaine 4 Percent Plus Cream

Drug Facts

Composition & Product

Active Ingredients

Lidocaine (4 g)

Inactive Ingredients

Water Arnica Montana Flower Indian Frankincense Cetostearyl Alcohol Chondroitin Sulfate (bovine) Ethylhexylglycerin Glucosamine Sulfate Glycerin Glyceryl Monostearate Isostearyl Palmitate Magnesium Sulfate, Unspecified Form Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Propylene Glycol Sodium Polyacrylate (2500000 Mw) Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-10-01

Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCl 4% w/w

Uses

Temporarily relieves pain and itching due to:

•
minor cuts
•
sunburn
•
minor scrapes
•
minor burns
•
insect bites
•
minor skin irritations

Warnings

For external use only.

Directions

adults and children 2 years and older	apply externally to the affected area up to 3 to 4 times a day
children under 2 years	ask a doctor

Active Ingredient

Lidocaine HCl 4% 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.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, Magnesium Sulfate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

Principal Display Panel

NDC 50488-6263-1

Lidocaine 4% PLUS Cream

120 grams

Manufactured for: Alexso, Inc.

2317 Cotner Avenue Los Angeles, CA 90064

Tel: 888.495.6078 Web: www.alexso.com

Label

When Using This Product

•
do not use in or near the eyes
•
do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use and Ask A Doctor If

•
allergic reaction occurs
•
condition worsens or does not improve within 7 days
•
symptoms clear up and return within a few days
•
redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out of Reach of Children.

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

Structured Label Content

Uses

Temporarily relieves pain and itching due to:

•
minor cuts
•
sunburn
•
minor scrapes
•
minor burns
•
insect bites
•
minor skin irritations

Purpose

Topical anesthetic

Warnings

For external use only.

Directions

adults and children 2 years and older	apply externally to the affected area up to 3 to 4 times a day
children under 2 years	ask a doctor

Active Ingredient (Active ingredient)

Lidocaine HCl 4% 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.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, Magnesium Sulfate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50488-6263-1

Lidocaine 4% PLUS Cream

120 grams

Manufactured for: Alexso, Inc.

2317 Cotner Avenue Los Angeles, CA 90064

Tel: 888.495.6078 Web: www.alexso.com

Label

When Using This Product (When using this product)

•
do not use in or near the eyes
•
do not use in large quantities, particularly over raw surfaces or blistered areas

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

•
allergic reaction occurs
•
condition worsens or does not improve within 7 days
•
symptoms clear up and return within a few days
•
redness, irritation, swelling, pain or other symptoms begin or increase

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves pain and itching due to: • minor cuts • sunburn • minor scrapes • minor burns • insect bites • minor skin irritations", "Purpose": "Topical anesthetic", "Warnings": "For external use only.", "Directions": "adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor", "Active ingredient": "Lidocaine HCl 4% 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.", "Inactive ingredients": "Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, Magnesium Sulfate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.", "PRINCIPAL DISPLAY PANEL": "NDC 50488-6263-1 Lidocaine 4% PLUS Cream 120 grams Manufactured for: Alexso, Inc. 2317 Cotner Avenue Los Angeles, CA 90064 Tel: 888.495.6078 Web: www.alexso.com Label", "When using this product": "• do not use in or near the eyes • do not use in large quantities, particularly over raw surfaces or blistered areas", "Stop use and ask a doctor if": "• allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • redness, irritation, swelling, pain or other symptoms begin or increase", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Lidocaine 4 Percent Plus Cream

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information