Advanced Numb Topical Anesthetic

Advanced Numb Topical Anesthetic
SPL v10
SPL
SPL Set ID 859d1cad-badf-4c42-9b08-daacb3fae8b4
Route
TOPICAL
Published
Effective Date 2018-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Benzyl Alcohol Carboxypolymethylene Propylene Glycol .alpha.-tocopherol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-04-20 Until 2020-12-31

Description

Lidocaine HCL (5%)

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine HCL (5%)

Use

For the temporary relief of pain and discomfort associated with anorectal disorders.

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.

Warnings

For external use only. If condition worsens or does not improve within 7 days, consult a doctor.

Drug Facts

Directions

Adults and children 12 years and older:  For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product.

Apply externally up to 6 times per day.

Children under 12: Consult a Doctor.

Other Information

Store at room temperature. Avoid Direct sunlight.

Package Labeling:

Active Ingredients

Lidocaine HCL (5%)

Inactive Ingredients

Allantoin Gel, Deionized Water, Benzyl Alcohol, Carbomer, Pro-pylene GLycol, Sodim Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine

Keep Out of Reach of Children.

If swallowed, get medical help or contact the Poison Control Center immediately.


Structured Label Content

Use

For the temporary relief of pain and discomfort associated with anorectal disorders.

Purpose

External Analgesic

Do Not  (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.

Warnings

For external use only. If condition worsens or does not improve within 7 days, consult a doctor.

Drug Facts (DRUG FACTS)

Directions

Adults and children 12 years and older:  For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product.

Apply externally up to 6 times per day.

Children under 12: Consult a Doctor.

Other Information

Store at room temperature. Avoid Direct sunlight.

Package Labeling:

Active Ingredients

Lidocaine HCL (5%)

Inactive Ingredients (Inactive ingredients)

Allantoin Gel, Deionized Water, Benzyl Alcohol, Carbomer, Pro-pylene GLycol, Sodim Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact the Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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