MANDELIC 2 PEEL GEL- allantoin gel

Mandelic 2 Peel Gel by

Drug Labeling and Warnings

Mandelic 2 Peel Gel by is a Otc medication manufactured, distributed, or labeled by MESO SYSTEM S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Is for the skin that combines the coetaneus photo aging with acne and hyperpigmentation.

KEEP OUT OF REACH OF CHILDREN

• Keep out of the reach of chuldren.
• In case of overdose get medical help or Contact a Poison Control Center right away.

DIRECTIONS

Apply the content with a brush. The time of application is 1 to 2 minutes. Rinse with cold water.

QUESTIONS OR COMMENTS ?

• +35 1227347125 M-F: 9:00 am to 5:00 pm

ACTIVE INGREDIENTS

Active Ingredients Purpose

Allantoin 0.1%...................................................................................................................................................Skin Protectant

Inactive Ingredients

water, mandelic acid, hydroxyethyl ethylcellulose, alcohol denat, propanediol, phenoxyethanol, ethylhexylglycerin

INDICATIONS & USAGE

Is for the skin that combines the coetaneus photo aging with acne and hyperpigmentation.

Mandelic_2 Peel Gel

Mandelic_2 Peel Gel

Skin Protecting

INGREDIENTS AND APPEARANCE

MANDELIC 2 PEEL GEL 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70663-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)	2 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	89.9 mg  in 1 mL
MANDELIC ACID (UNII: NH496X0UJX)	4.5 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	1 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.1 mg  in 1 mL
PROPANEDIOL (UNII: 5965N8W85T)	1 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M)	1.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70663-003-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/05/2016

Labeler - MESO SYSTEM S.A. (768263100)

Registrant - MESO SYSTEM S.A. (768263100)

Establishment
Name	Address	ID/FEI	Business Operations
MESO SYSTEM S.A.		768263100	manufacture(70663-003)