Label: DESMAQUILLANTE OJOS WEYE- makeup remover cream
LIMPIADOR DE OJOS WEYE- eye cleansing gel
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Contains inactivated NDC Code(s)
NDC Code(s): 82222-001-01, 82222-010-01 - Packager: WEYE LABORATORY GROUP S.L.
- 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
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INGREDIENTS AND APPEARANCE
DESMAQUILLANTE OJOS WEYE
makeup remover creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82222-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 U in 1 U Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82222-001-01 1 U in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/07/2021 LIMPIADOR DE OJOS WEYE
eye cleansing gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82222-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 U in 1 U Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82222-010-01 1 U in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/07/2021 Labeler - WEYE LABORATORY GROUP S.L. (470489128) Registrant - WEYE LABORATORY GROUP S.L. (470489128) Establishment Name Address ID/FEI Business Operations WEYE LABORATORY GROUP S.L. 470489128 label(82222-001, 82222-010) , manufacture(82222-001, 82222-010) , pack(82222-001, 82222-010)