DESMAQUILLANTE OJOS WEYE- makeup remover cream 
LIMPIADOR DE OJOS WEYE- eye cleansing gel 
WEYE LABORATORY GROUP S.L.

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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ACTIVE INGREDIENT

ACTIVE INGREDIENT

PURPOSE

PURPOSE AND USES

WARNINGS AND PRECAUTION

WARNINGS AND PRECAUTION

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

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)

Revised: 9/2021
Document Id: cb68bec5-9e55-1664-e053-2995a90a5eab
Set id: cb68bec5-9e54-1664-e053-2995a90a5eab
Version: 1
Effective Time: 20210907
 
WEYE LABORATORY GROUP S.L.