Melao Numb Cream

Melao Numb Cream
SPL v1
SPL
SPL Set ID 1d19cf67-8bd3-270e-e063-6294a90a1a47
Route
TOPICAL
Published
Effective Date 2024-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine N2-oxide (20 g)
Inactive Ingredients
Mentha Arvensis Leaf Portulaca Oleracea Leaf Propylene Glycol 1-(2-methylbutyrate) 1,2-hexanediol Water Hydroxyacetophenone Tetracaine Glycerin Disodium Edta-copper Chrysanthellum Indicum Flower Prilocaine Hydrogenated Castor Oil Carbomer 980

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-04

Description

Aqua. PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA, HYDROXYACETOPHENONE.1.2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT, CHRYSANTHELLUM INDICUM EXTRACT.PORTULACA OLERACEA EXTRACT, PEG-40 HYDROGENATED CASTOR OIL,TETRACAINE,PRILOCAINE


Medication Information

Warnings and Precautions

For external use only.

Seal the product and avoidlight, store in a cool and dnpiace.

Indications and Usage

1.Adults: When practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of the product.

2. Apply externally to the affected area up to 6 timesdaily.

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

Dosage and Administration

1.Adults: When practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of the product.

2. Apply externally to the affected area up to 6 timesdaily.

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

Description

Aqua. PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA, HYDROXYACETOPHENONE.1.2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT, CHRYSANTHELLUM INDICUM EXTRACT.PORTULACA OLERACEA EXTRACT, PEG-40 HYDROGENATED CASTOR OIL,TETRACAINE,PRILOCAINE

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if allergic reaction occurs rectal bleeding occurs redness, iritation, swelling,pain or other symptoms begin or increase condition worsens or does not improve within 7 days

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

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

Do not put into the rectum by using fngers or any mechanical device or applicator.

Section 51727-6

Aqua. PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA, HYDROXYACETOPHENONE.1.2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT, CHRYSANTHELLUM INDICUM EXTRACT.PORTULACA OLERACEA EXTRACT, PEG-40 HYDROGENATED CASTOR OIL,TETRACAINE,PRILOCAINE

Section 51945-4

Section 55105-1

For temporary relief of local discomfort, itching,pain,soreness or burning in the perianal area associated with anorectal disorders.

Section 55106-9

LIDOCAINE


Structured Label Content

Indications and Usage (34067-9)

1.Adults: When practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of the product.

2. Apply externally to the affected area up to 6 timesdaily.

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

Dosage and Administration (34068-7)

1.Adults: When practical, cleanse the affected area with mild soap, and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of the product.

2. Apply externally to the affected area up to 6 timesdaily.

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

Warnings and Precautions (34071-1)

For external use only.

Seal the product and avoidlight, store in a cool and dnpiace.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if allergic reaction occurs rectal bleeding occurs redness, iritation, swelling,pain or other symptoms begin or increase condition worsens or does not improve within 7 days

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

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

Do not put into the rectum by using fngers or any mechanical device or applicator.

Section 51727-6 (51727-6)

Aqua. PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA, HYDROXYACETOPHENONE.1.2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT, CHRYSANTHELLUM INDICUM EXTRACT.PORTULACA OLERACEA EXTRACT, PEG-40 HYDROGENATED CASTOR OIL,TETRACAINE,PRILOCAINE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For temporary relief of local discomfort, itching,pain,soreness or burning in the perianal area associated with anorectal disorders.

Section 55106-9 (55106-9)

LIDOCAINE


Advanced Ingredient Data


Raw Label Data

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