MADECASSOL- neomycin sulfate, titrated ext. of centella asiatica ointment

MADECASSOL by

Drug Labeling and Warnings

MADECASSOL by is a Otc medication manufactured, distributed, or labeled by LYDIA Co., Ltd, I World Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Neomycin Sulfate, Titrated Ext. of Centella Asiatica

PURPOSE

■ temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

WARNINGS

For external use only.

Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.

When using this product consult a doctor before exceeding recommended dosage.

Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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

INACTIVE INGREDIENT

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

DOSAGE & ADMINISTRATION

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MADECASSOL 
neomycin sulfate, titrated ext. of centella asiatica ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72988-0018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	10 mg  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72988-0018-1	10 g in 1 TUBE; Type 0: Not a Combination Product	10/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/08/2019

Labeler - LYDIA Co., Ltd (695735569)

Registrant - LYDIA Co., Ltd (695735569)

Establishment
Name	Address	ID/FEI	Business Operations
I World Pharmaceutical Co., Ltd		688222857	manufacture(72988-0018)

Establishment
Name	Address	ID/FEI	Business Operations
LYDIA Co., Ltd		695735569	label(72988-0018)