MELAO NUMB CREAM- lidocaine 20% oil

MELAO Numb Cream by

Drug Labeling and Warnings

MELAO Numb Cream by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yilong Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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

ACTIVE INGREDIENT

LIDOCAINE

PURPOSE

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

INDICATIONS & 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.

WARNINGS

For external use only.

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

STOP USE

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

DO NOT USE

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.

WHEN USING

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

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.

DOSAGE & 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MELAO NUMB CREAM 
lidocaine 20% oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE N2-OXIDE (UNII: 25797M378Y) (LIDOCAINE N2-OXIDE - UNII:25797M378Y)	LIDOCAINE N2-OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TETRACAINE (UNII: 0619F35CGV)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CHRYSANTHELLUM INDICUM FLOWER (UNII: LG4H57M77Y)
PRILOCAINE (UNII: 046O35D44R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CARBOMER 980 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-257-01	30 g in 1 TUBE; Type 0: Not a Combination Product	07/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	07/04/2024

Labeler - Guangzhou Yilong Cosmetics Co., Ltd (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co., Ltd		712647107	manufacture(83566-257)