Label: MANDELIC 2 PEEL GEL- allantoin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 5, 2016

If you are a consumer or patient please visit this version.

  • 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

    Bottle

  • INGREDIENTS AND APPEARANCE
    MANDELIC 2 PEEL GEL 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70663-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70663-003-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/05/2016
    Labeler - MESO SYSTEM S.A. (768263100)
    Registrant - MESO SYSTEM S.A. (768263100)
    Establishment
    NameAddressID/FEIBusiness Operations
    MESO SYSTEM S.A.768263100manufacture(70663-003)