Dr Wellskin Numbing Cream

Dr Wellskin Numbing Cream
SPL v1
SPL
SPL Set ID 482f25cc-dee3-c3b6-e063-6294a90a8674
Route
TOPICAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Carbomer 1,2-hexanediol Hydroxyacetophenone Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-12

Description

For external use only.


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Adults and children 12 years and older: When practical, cleanse theaffected 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.

Apply a thin layer of cream to the affected area up to 6 times daily as needed.

Children under 12 years: Consult a doctor.

Dosage and Administration

Adults and children 12

years and older: Apply a

thin layer to the affected

area 1-3 times daily or

as directed by a

healthcare provider.

Description

For external use only.

Section 50565-1

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

away.

Section 50566-9

Allergic reaction occurs.

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Redness, irritation, sweling, pain, or other symptoms begin or increase.

Section 50567-7

Do not exceed the recommended daily dosage unless directed by adoctor

Do not insert into the rectum using fingers or any mechanical device orapplicator

Section 51727-6

Water, Propylene Glycol, Glycerin, Carbomer, Disodium EDTA, Hydroxyacetophenone, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Mentha Arvensis Leaf Extract, Chrysanthellum Indicum Extract, Portulaca Oleracea Extract,Tocopheryl Acetate.

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

4% Lidocaine


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years and older: When practical, cleanse theaffected 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.

Apply a thin layer of cream to the affected area up to 6 times daily as needed.

Children under 12 years: Consult a doctor.

Dosage and Administration (34068-7)

Adults and children 12

years and older: Apply a

thin layer to the affected

area 1-3 times daily or

as directed by a

healthcare provider.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

away.

Section 50566-9 (50566-9)

Allergic reaction occurs.

Rectal bleeding occurs.

Condition worsens or does not improve within 7 days.

Redness, irritation, sweling, pain, or other symptoms begin or increase.

Section 50567-7 (50567-7)

Do not exceed the recommended daily dosage unless directed by adoctor

Do not insert into the rectum using fingers or any mechanical device orapplicator

Section 51727-6 (51727-6)

Water, Propylene Glycol, Glycerin, Carbomer, Disodium EDTA, Hydroxyacetophenone, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Mentha Arvensis Leaf Extract, Chrysanthellum Indicum Extract, Portulaca Oleracea Extract,Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

4% Lidocaine


Advanced Ingredient Data


Raw Label Data

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