Label: DESMAQUILLANTE OJOS WEYE- makeup remover cream
LIMPIADOR DE OJOS WEYE- eye cleansing 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 September 7, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

  • PURPOSE

    PURPOSE AND USES

  • WARNINGS AND PRECAUTION

    WARNINGS AND PRECAUTION

  • WARNINGS

    WARNINGS

  • ASK DOCTOR

    ASK DOCTOR

  • KEEP OUT

    KEEP OUT

  • QUESTIONS

    QUESTIONS

  • PREGNANCY

    PREGNANCY WARNING

  • indications

    indications

  • dosage

    dosage

  • inactive ingredients

    inactive ingredients

  • indications and usage

    indications and usage

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    gelfoam

  • INGREDIENTS AND APPEARANCE
    DESMAQUILLANTE OJOS WEYE 
    makeup remover cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82222-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 U  in 1 U
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT) 1 U  in 1 U
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 1 U  in 1 U
    SODIUM BENZOATE (UNII: OJ245FE5EU) 1 U  in 1 U
    WATER (UNII: 059QF0KO0R) 1 U  in 1 U
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 1 U  in 1 U
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1 U  in 1 U
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) 1 U  in 1 U
    ALLANTOIN (UNII: 344S277G0Z) 1 U  in 1 U
    SODIUM LEVULINATE (UNII: VK44E1MQU8) 1 U  in 1 U
    SODIUM ANISATE (UNII: F9WFJ28MV9) 1 U  in 1 U
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 1 U  in 1 U
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) 1 U  in 1 U
    MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG) 1 U  in 1 U
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) 1 U  in 1 U
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8) 1 U  in 1 U
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) 1 U  in 1 U
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 1 U  in 1 U
    CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP) 1 U  in 1 U
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82222-001-011 U in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/07/2021
    LIMPIADOR DE OJOS WEYE 
    eye cleansing gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82222-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 U  in 1 U
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT) 1 U  in 1 U
    SODIUM BENZOATE (UNII: OJ245FE5EU) 1 U  in 1 U
    WATER (UNII: 059QF0KO0R) 1 U  in 1 U
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 1 U  in 1 U
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1 U  in 1 U
    ALLANTOIN (UNII: 344S277G0Z) 1 U  in 1 U
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 1 U  in 1 U
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) 1 U  in 1 U
    MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG) 1 U  in 1 U
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) 1 U  in 1 U
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8) 1 U  in 1 U
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) 1 U  in 1 U
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 1 U  in 1 U
    CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP) 1 U  in 1 U
    METHYLPROPANEDIOL (UNII: N8F53B3R4R) 1 U  in 1 U
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) 1 U  in 1 U
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) 1 U  in 1 U
    ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27) 1 U  in 1 U
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 U  in 1 U
    LAURETH-2 (UNII: D4D38LT1L5) 1 U  in 1 U
    PHENYLPROPANOL (UNII: 0F897O3O4M) 1 U  in 1 U
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) 1 U  in 1 U
    PEG-90 GLYCERYL ISOSTEARATE (UNII: 0MLT3369F0) 1 U  in 1 U
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82222-010-011 U in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/07/2021
    Labeler - WEYE LABORATORY GROUP S.L. (470489128)
    Registrant - WEYE LABORATORY GROUP S.L. (470489128)
    Establishment
    NameAddressID/FEIBusiness Operations
    WEYE LABORATORY GROUP S.L.470489128label(82222-001, 82222-010) , manufacture(82222-001, 82222-010) , pack(82222-001, 82222-010)