Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7c36a437-ed0a-4874-a0de-9022d5a5f7cf
Route
TOPICAL
Published
Effective Date 2022-06-28
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 C13-14 Isoparaffin Chondroitin 6-sulfate Dimethyl Sulfone Emu Oil Ethylhexylglycerin Glucosamine Sulfate Isopropyl Palmitate Lavandula Angustifolia Subsp. Angustifolia Flower Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Stearic Acid Triethanolamine Benzoate Laureth-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-01

Description

Lidocaine HCL 5.0% w/w

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine HCL 5.0% w/w

Uses

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

Section 50565-1

Warnings

For external use only

Avoid contact with eyes

Do not exceed the recommended daily dosage unless director by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using a finger or any medical device or applicator.

Stop use and ask doctor if

• Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use.

Keep out of reach of children

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

Directions

For adults, 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.

Apply externally to the affected area not more than 6 times daily. Children under 12 years of age: consult a physician.

Product Label

Active Ingredient

Lidocaine HCL 5.0% w/w

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua (Deionized Water), Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Isoprpoyl Palmitate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

Questions Or Comments?

FDA Registered: NDC No 82067-100-60

Toll -Free 1-844-EUROTAS


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

Purpose

External Analgesic

Warnings

For external use only

Avoid contact with eyes

Do not exceed the recommended daily dosage unless director by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using a finger or any medical device or applicator.

Stop use and ask doctor if

• Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use.

Keep out of reach of children

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

Directions

For adults, 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.

Apply externally to the affected area not more than 6 times daily. Children under 12 years of age: consult a physician.

Product Label (Product label)

Active Ingredient

Lidocaine HCL 5.0% w/w

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua (Deionized Water), Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Isoprpoyl Palmitate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

Questions Or Comments? (Questions or Comments?)

FDA Registered: NDC No 82067-100-60

Toll -Free 1-844-EUROTAS


Advanced Ingredient Data


Raw Label Data

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