MELANO OUT CREAM- allantoin, glycerin cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z), GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)

Available from:

MESO SYSTEM S.A.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level - Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level

Authorization status:

OTC monograph final

Summary of Product characteristics

MELANO OUT CREAM- ALLANTOIN, GLYCERIN CREAM
MESO SYSTEM S.A.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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MELANO OUT CREAM
WARNINGS
STOP USE AND ASK A DOCTOR IF RASH OCCURS
WARNINGS
For external use only.
Do no use on damaged or broken skin
Stop use and ask a doctor if rash occurs
Avoid the product from entering your eyes
Children under 6 months Ask a Doctor
USES
Cream formulated to atenuate and eliminate the coetaneus spot of
melanic origin located at the
epidermic level
Keep out of the reach of chuldren.
In case of overdose get medical help or Contact a Poison Control
Center right away.
DIRECTIONS
Clean the skin thoroughly before applying the cream.
Cover the entire affected area with a thin layer. First week apply
three times daily (morning-
afternoon-night). Second week apply two times daily (morning-night).
Third week apply once a day
for one year.
During summer it is recommended the application of the cream after sun
exposure. If bothersome
dryness or peeling occurs, reduce application to once a day or every
other day
QUESTIONS OR COMMENTS ?
[phone] M-F: 9:00 am to 5:00 pm
ACTIVE INGREDIENTS
ACTIVE INGREDIENTS PURPOSE
Allantoin 0.01%................................Skin Protectant
Glycerin 0.25%.................................Skin Protectant
INACTIVE INGREDIENTS
Water, Azelaic Acid, Mineral Oil, Ethylhexyl Methoxycinnamate,
Cetearyl Alcohol, Salicylic Acid,
Kojic Acid,,Arbutin, Phenoxyethanol, Glycyrrhetinic Acid, Citric Acid,
Lactic Acid, Phytic Acid,
Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Ascorbic Acid, Sodium,
Lactate, Serine, Sorbitol,
Tea-lactate, Urea, Ethylhexylglycerin, Sodium Chloride
Cream formulated to atenuate and eliminate the coetaneus spot of
melanic origin located at the
epidermic level
MELANO OUT CREAM
MELANO OUT CREAM
SKIN PROTECTING
MELANO OUT CREAM
allantoin, glycerin cream
PRODUCT INFORMATION
PRODUCT