Lidocaine Numbing Cream Topical Anesthetic Cream With Vitamin E

Lidocaine Numbing Cream Topical Anesthetic Cream With Vitamin E
SPL v3
SPL
SPL Set ID fe986c22-a30c-4d60-90d0-5d41e0b91958
Route
TOPICAL
Published
Effective Date 2023-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer 940 Cholesterol Lecithin, Soybean Isopropyl Myristate Polysorbate 80 Propylene Glycol Water Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-17

Description

Lidocaine HCl 5.0%

Purpose

External Analgesic


Medication Information

Purpose
  • External Analgesic
Description

Lidocaine HCl 5.0%

Uses:

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

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

Children under 12: Consult a doctor.

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.

Packaging Label
Active Ingredient:

Lidocaine HCl 5.0%

Other Information:

Store at room temperature. Avoid direct sunlight. Do not use if tamper evident packaging has been breached or is missing. See bottom of this jar for lot number and expiry date.

Distributed by: Wellspring Airmont, NY 10952 U.S.A.

Inactive Ingredients

Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate

When Using This Product,
  • 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.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact the Poison Control Center immediately.
  • If pregnant or breast feeding, ask a health professional before use.
Keep Out of Reach of Children.


Structured Label Content

Uses:

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

Purpose
  • External Analgesic
Warnings:
  • For external use only. If condition worsens or does not improve within 7 days, consult a doctor.
Directions:

Children under 12: Consult a doctor.

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.

Packaging Label (Packaging label)
Active Ingredient:

Lidocaine HCl 5.0%

Other Information:

Store at room temperature. Avoid direct sunlight. Do not use if tamper evident packaging has been breached or is missing. See bottom of this jar for lot number and expiry date.

Distributed by: Wellspring Airmont, NY 10952 U.S.A.

Inactive Ingredients

Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate

When Using This Product, (When using this product,)
  • 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.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact the Poison Control Center immediately.
  • If pregnant or breast feeding, ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)


Advanced Ingredient Data


Raw Label Data

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