MEGAPLAST - CLARIFYING ACNE PATCHES- salicylic acid patch

Megaplast - Clarifying Acne Patches by

Drug Labeling and Warnings

Megaplast - Clarifying Acne Patches by is a Otc medication manufactured, distributed, or labeled by EUROSIREL SPA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid

WARNINGS

For External Use Only.

WHEN USING

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at the same time.

PURPOSE

Acne Treatment

Directions

• Clean the skin thoroughly before applying this product
• Peel off the patch from the transparent support and carefully apply on the affected zone for no less than 6 hours, maximum 12 hours
• Cover the entire affected area with a thin layer one to three times daily if needed or as directed by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Use

• For impurities of the skin. Our innovative cosmetic patches help to correct blemishes of the skin with acneic and comedonic tendency.

DO NOT USE

Do not use

• if you are diabetic
• if you are pregnant
• if you have poor blood circulation
• for women who breastfeed
• for children younger than 16 years old
• on irritated skin or on any area that is infected or reddened

In case of contact with the eyes, rinse with plenty of water.

Keep in a dry and cool place.

Disposable product

For Acneic skins.

DO NOT USE IF YOU ARE ALLERGIC TO PEANUT OR SOYA.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

ASK DOCTOR

If discomfort persists, see your doctor.

STORAGE AND HANDLING

Store below 30ºC (66ºF)

INACTIVE INGREDIENT

Grape Seed Oil, Lavender Oil, Soybean Oil, Tea Tree Oil, Ascorbyl Palmitate, Acrylic Acid Copolymer, Melaleuca Altermifolia Leaf, Linalool

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEGAPLAST - CLARIFYING ACNE PATCHES 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71235-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.056 mg

Inactive Ingredients
Ingredient Name	Strength
GRAPE SEED OIL (UNII: 930MLC8XGG)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SOYBEAN OIL (UNII: 241ATL177A)
TEA TREE OIL (UNII: VIF565UC2G)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71235-004-01	30 in 1 BOX; Type 0: Not a Combination Product	07/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/14/2017

Labeler - EUROSIREL SPA (655512069)

Registrant - EUROSIREL SPA (655512069)

Establishment
Name	Address	ID/FEI	Business Operations
EUROSIREL SPA		655512069	manufacture(71235-004)