OTC Medication Information: MADECASSOL

MADECASSOL- centella asiatica and neomycin sulfate ointment
LYDIA Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Neomycin Sulfate, Titrated Ext. of Centella Asiatica

■ 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

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

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.

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

For external use only

1

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CENTELLA ASIATICA (CENTELLA ASIATICA) CENTELLA ASIATICA 10 mg in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
CETOSTEARYL ALCOHOL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72988-0018-1 10 g in 1 TUBE None
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 Operations
I World Pharmaceutical Co., Ltd 688222857 manufacture (72988-0018)
Establishment
Name Address ID/FEI Operations
LYDIA Co., Ltd 695735569 label (72988-0018)

Revised: 10/2019 LYDIA Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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