SPL v1
SPL
SPL Set ID 36c9988b-9e61-ebbf-e063-6394a90a4114
Route
TOPICAL
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 mg)
Inactive Ingredients
Triethanolamine Propylene Glycol Sodium Polyacrylate (2500000 Mw) Hydrogenated Polydecene (1500 Cst) Lecithin, Soybean Trideceth-6 Cholesterol Aloe Barbadensis Leaf Juice .alpha.-tocopherol Acetate, D- Water Benzyl Alcohol Carbomer Dimethyl Isosorbide Neopentyl Glycol Dicaprylate/dicaprate Disodium Edta-copper Allantoin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-07

Description

Active Ingredient - Lidocaine 5%


Medication Information

Warnings and Precautions

Warnings (For external use only)

■ If condition worsens or does not improve within 7 days, consult a doctor.

■ Do not exceed the recommended daily dosage unless directed by a doctor.

■ In case of bleeding, consult a doctor promptly.

■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.

■ 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 and consult a doctor.

Indications and Usage

Uses

■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.

■ For the temporary relief of pain, burning and soreness.

Dosage and Administration

■ 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. Children under 12 years of age: consult a doctor.

■ Apply externally to the affected area up to 6 times daily.

Description

Active Ingredient - Lidocaine 5%

Section 50565-1

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

Section 51727-6

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine, Water

Section 51945-4

Section 55105-1

Purpose………………………………………….Local Anesthetic

Section 55106-9

Active Ingredient - Lidocaine 5%


Structured Label Content

Indications and Usage (34067-9)

Uses

■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.

■ For the temporary relief of pain, burning and soreness.

Dosage and Administration (34068-7)

■ 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. Children under 12 years of age: consult a doctor.

■ Apply externally to the affected area up to 6 times daily.

Warnings and Precautions (34071-1)

Warnings (For external use only)

■ If condition worsens or does not improve within 7 days, consult a doctor.

■ Do not exceed the recommended daily dosage unless directed by a doctor.

■ In case of bleeding, consult a doctor promptly.

■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.

■ 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 and consult a doctor.

Section 50565-1 (50565-1)

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

Section 51727-6 (51727-6)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose………………………………………….Local Anesthetic

Section 55106-9 (55106-9)

Active Ingredient - Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

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