ULTRUE The True Rich Cream - Revitalizing Hydrogel Mask by Imine Co., Ltd 59401-022_Deactivation

ULTRUE The True Rich Cream - Revitalizing Hydrogel Mask by

Drug Labeling and Warnings

ULTRUE The True Rich Cream - Revitalizing Hydrogel Mask by is a Otc medication manufactured, distributed, or labeled by Imine Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRUE THE TRUE RICH CREAM - REVITALIZING HYDROGEL MASK- allantoin cream 
Imine Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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59401-022_Deactivation

Allantoin (0.03%)

Revitalizing

1. Avoid contact with eyes. In case contact with eyes, rinse immediately with water. 2. Use with caution if you are highly sensitive to any bandages or wet compresses. 3. Do not use the product on an open skin wound or on areas of eczema or infection. 4. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 5. Storage and handling instructions. 1) Apply immediately after removing it from packaging because it can dry up. 2) Keep out of reach of children. 3) Avoid exposure to high or low temperatures

Apply one mask sheet at a time.

Skin Protectant

1. After cleansing your face, apply some skin toner. 2. Open the package and remove the protective upper and lower films. 3. Apply the mask sheets evenly on your face keeping the eye and mouth area clear. 4. Remove the mask in about 30 minutes and gently use your fingers to pat any remaining product into the skin until thoroughly absorbed. *Apply the lower sheet first. *Place the side where the protective film was on your skin.

Keep out of reach of children.

If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above.

Avoid contact with eyes. In case contact with eyes, rinse immediately with water.

Do not use the product on an open skin wound or on areas of eczema or infection.

Water
Glycerin
Butylene Glycol
Cetyl Ethylhexanoate
Caprylic/Capric Triglyceride
Citrus Paradisi (Grapefruit) Fruit Extract
Glyceryl Stearate
Ceratonia Siliqua Gum
Chondrus Crispus (Carrageenan)
Polyglyceryl-3 Methylglucose Distearate
PEG-100 Stearate
Dimethicone
Anastatica Hierochuntica Extract
Cellulose Gum
Hydrogenated Vegetable Oil
Tamarindus Indica Seed Gum
Sodium Polyacrylate
Caesalpinia Spinosa Gum
Carbomer
Hydrogenated Polydecene
Potassium Hydroxide
Trideceth-6
Lactobacillus Ferment
Silica
Larrea Tridentata Extract
Fouqueria Splendens Stem Extract
Yucca Brevifolia Root Extract
Agave Americana Stem Extract
Opuntia Coccinellifera Flower Extract
Abronia Villosa Leaf Extract
Oenothera Biennis (Evening Primrose) RootExtract
1,2-Hexanediol
Helianthus Annuus (Sunflower) Seed Oil
Polyquaternium-51
Ammonium Acryloyldimethyltaurate/VPCopolymer
Persea Gratissima (Avocado) Oil
Sodium Hyaluronate
Oenothera Biennis (Evening Primrose) Oil
Disodium EDTA
Phenoxyethanol
Fragrance

True Rich Cream Revitalizing

ULTRUE THE TRUE RICH CREAM - REVITALIZING HYDROGEL MASK 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59401-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0075 g  in 25 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LOCUST BEAN GUM (UNII: V4716MY704)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CORN OIL (UNII: 8470G57WFM)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)  
FOUQUIERIA SPLENDENS STEM (UNII: 321SWI055M)  
YUCCA BREVIFOLIA ROOT (UNII: KC82I6XYAZ)  
AGAVE AMERICANA STEM (UNII: 21BU87042T)  
OPUNTIA COCHENILLIFERA FLOWER (UNII: A8ZJY40G5N)  
ABRONIA VILLOSA LEAF (UNII: A138B5260A)  
OENOTHERA BIENNIS ROOT (UNII: SL194W0S0F)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
POLYQUATERNIUM-53 (UNII: FLN8G45C73)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59401-022-0125 g in 1 POUCH; Type 0: Not a Combination Product02/25/201512/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/25/201512/27/2019
Labeler - Imine Co., Ltd (557816813)
Registrant - Imine Co., Ltd (557816813)
Establishment
NameAddressID/FEIBusiness Operations
i Mine Co.,Ltd.557816813manufacture(59401-022)

Revised: 12/2019
 
Imine Co., Ltd