Etaderm Numbing Cream

Etaderm Numbing Cream
SPL v4
SPL
SPL Set ID 5292c6ff-b878-4e71-878b-4bf08207612e
Route
TOPICAL
Published
Effective Date 2025-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Cholesterol Hydrogenated Soybean Lecithin Isopropyl Myristate Polysorbate 80 Propylene Glycol Water Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-15

Description

Lidocaine 5 %

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5 %

Uses:

For temporary relief of local and Anorectal discomfort associated with Anorectal discomfort or inflammation

Section 51945-4

Warnings:

For external use only

Questions?

424-354-4370

Directions:

▪ Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement ▪ Children under 12 years of age: consult a doctor.

Active Ingredients

Lidocaine 5 %

Inactive Ingredients:

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

When Using This Product
  • ▪ do not get into eyes. ▪ do not exceed the recommended daily dosage unless directed by a doctor ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask A Doctor If
  • ▪ condition worsens or does not improve within 7 days. ▪ in case of bleeding, consult a doctor promptly ▪ 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.
Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding, 

ask a health professional before use


Structured Label Content

Uses:

For temporary relief of local and Anorectal discomfort associated with Anorectal discomfort or inflammation

Section 51945-4 (51945-4)

Purpose

Local Anesthetic

Warnings:

For external use only

Questions?

424-354-4370

Directions:

▪ Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement ▪ Children under 12 years of age: consult a doctor.

Active Ingredients

Lidocaine 5 %

Inactive Ingredients:

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

When Using This Product (When using this product)
  • ▪ do not get into eyes. ▪ do not exceed the recommended daily dosage unless directed by a doctor ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • ▪ condition worsens or does not improve within 7 days. ▪ in case of bleeding, consult a doctor promptly ▪ 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.
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.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use


Advanced Ingredient Data


Raw Label Data

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