Hoyu America Co. / IDENTIPAK INC / Bigen Moisture plus Deep Conditioner (additional pouch 20ml) (53-833374-231049) / Bigen Easy Color Cream Colorant 2RB(53-605978-367590) / Bigen Easy Color Cream Colorant 3RA (53-444269-286779) / Bigen Easy Color Cream Developer H (53-324500-587872) / Bigen Easy Color Cream Colorant 4RC (53-375660-645308)

Drug Labeling and Warnings

Drug Details [pdf]

BIGEN EASY COLOR CREAM COLORANT 2RB(53-605978-367590)- hair dyes and colors (all types requiring caution statement and patch test) [hair coloring preparations]    
BIGEN EASY COLOR CREAM COLORANT 3RA (53-444269-286779)- hair dyes and colors (all types requiring caution statement and patch test) [hair coloring preparations]    
BIGEN EASY COLOR CREAM DEVELOPER H (53-324500-587872)- other hair coloring preparations, rinse-off [hair coloring preparations]    
BIGEN MOISTURE PLUS DEEP CONDITIONER (ADDITIONAL POUCH 20ML) (53-833374-231049)- hair conditioners, rinse-off [hair preparations (non-coloring)]    
BIGEN EASY COLOR CREAM COLORANT 4RC (53-375660-645308)- hair dyes and colors (all types requiring caution statement and patch test) [hair coloring preparations]    
Hoyu America Co.

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BIGEN EASY COLOR CREAM COLORANT 2RB(53-605978-367590) 
hair dyes and colors (all types requiring caution statement and patch test) [hair coloring preparations]
Product Information
Product Type
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRFRAGRANCE ()  
INGRACID YELLOW 3 ()  
INGRARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRBHT ()  
INGRCOCOS NUCIFERA (COCONUT) OIL ()  
INGRETHANOLAMINE ()  
INGRISOPROPYL ALCOHOL (UNII: ND2M416302)  
INGRMICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
INGROLEA EUROPAEA (OLIVE) FRUIT OIL ()  
INGROLETH-50 (UNII: 05572M2K90)  
INGRPEG-8 ()  
INGRPETROLATUM (UNII: 4T6H12BN9U)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRSTEARETH-2 (UNII: V56DFE46J5)  
INGRSTEARTRIMONIUM CHLORIDE ()  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRTAURINE (UNII: 1EQV5MLY3D)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRTRISODIUM HEDTA (UNII: K3E0U7O8KI)  
INGRWATER (UNII: 059QF0KO0R)  
INGR1-HYDROXYETHYL 4,5-DIAMINO PYRAZOLE SULFATE ()  
INGR1-NAPHTHOL (UNII: 2A71EAQ389)  
INGR2,4-DIAMINOPHENOXYETHANOL HCL ()  
INGR4-AMINO-2-HYDROXYTOLUENE (UNII: UBB8XEB10B)  
INGRP-AMINOPHENOL (UNII: R7P8FRP05V)  
INGRTOLUENE-2,5-DIAMINE (UNII: 24JO8Z0RJU)  
INGRARGANIA SPINOSA KERNEL OIL ()  
BIGEN EASY COLOR CREAM COLORANT 3RA (53-444269-286779) 
hair dyes and colors (all types requiring caution statement and patch test) [hair coloring preparations]
Product Information
Product Type
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRACID YELLOW 3 ()  
INGRARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRBHT ()  
INGRCOCOS NUCIFERA (COCONUT) OIL ()  
INGRETHANOLAMINE ()  
INGRISOPROPYL ALCOHOL (UNII: ND2M416302)  
INGRMICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
INGROLEA EUROPAEA (OLIVE) FRUIT OIL ()  
INGROLETH-50 (UNII: 05572M2K90)  
INGRPEG-8 ()  
INGRPETROLATUM (UNII: 4T6H12BN9U)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRSTEARETH-2 (UNII: V56DFE46J5)  
INGRSTEARTRIMONIUM CHLORIDE ()  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRTAURINE (UNII: 1EQV5MLY3D)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRTRISODIUM HEDTA (UNII: K3E0U7O8KI)  
INGRWATER (UNII: 059QF0KO0R)  
INGR1-HYDROXYETHYL 4,5-DIAMINO PYRAZOLE SULFATE ()  
INGR4-AMINO-2-HYDROXYTOLUENE (UNII: UBB8XEB10B)  
INGRARGANIA SPINOSA KERNEL OIL ()  
INGRFRAGRANCE ()  
INGRM-AMINOPHENOL (UNII: L3WTS6QT82)  
INGRP-PHENYLENEDIAMINE (UNII: U770QIT64J)  
BIGEN EASY COLOR CREAM DEVELOPER H (53-324500-587872) 
other hair coloring preparations, rinse-off [hair coloring preparations]
Product Information
Product Type
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCETETH-2 (UNII: 7H8VAM7778)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRCITRIC ACID ()  
INGRISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPPG-4-CETETH-20 (UNII: H5BK97949J)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRSTEARTRIMONIUM CHLORIDE ()  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRWATER (UNII: 059QF0KO0R)  
INGRHYDROGEN PEROXIDE (UNII: BBX060AN9V)  
BIGEN MOISTURE PLUS DEEP CONDITIONER (ADDITIONAL POUCH 20ML) (53-833374-231049) 
hair conditioners, rinse-off [hair preparations (non-coloring)]
Product Information
Product Type
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRFRAGRANCE ()  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRBUTYROSPERMUM PARKII(SHEABUTTER) ()  
INGRBEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
INGRPARAFFIN WAX ()  
INGRBEHENTRIMONIUM METHOSULFATE (AND) QUATERNIUM-87 (AND) CETEARYL ALCOHOL ()  
INGRCOCOS NUCIFERA (COCONUT) OIL ()  
INGRARGANIA SPINOSA KERNEL OIL ()  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRDISODIUM EDTA ()  
INGRWATER (UNII: 059QF0KO0R)  
INGRHYDROXYETHYLCELLULOSE ()  
INGRDIMETHICONE, DIMETHICONOL ()  
INGRAMODIMETHICONE/ MORPHOLINOMETHYL SILSESQUIOXANE COPOLYMER, TRIDECETH-5, GLYCERIN ()  
INGRLINOLEAMIDOPROPYL PG-DIMONIUM ()  
INGRAMODIMETHICONE ()  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRHYDROLYZED VEGETABLE PROTEIN PG-PROPYL SILANETRIOL (AND) WATER (AQUA) ()  
BIGEN EASY COLOR CREAM COLORANT 4RC (53-375660-645308) 
hair dyes and colors (all types requiring caution statement and patch test) [hair coloring preparations]
Product Information
Product Type
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRBHT ()  
INGRCOCOS NUCIFERA (COCONUT) OIL ()  
INGRETHANOLAMINE ()  
INGRISOPROPYL ALCOHOL (UNII: ND2M416302)  
INGRMICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
INGROLEA EUROPAEA (OLIVE) FRUIT OIL ()  
INGROLETH-50 (UNII: 05572M2K90)  
INGRPEG-8 ()  
INGRPETROLATUM (UNII: 4T6H12BN9U)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRSTEARETH-2 (UNII: V56DFE46J5)  
INGRACID YELLOW 3 ()  
INGRSTEARTRIMONIUM CHLORIDE ()  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRTAURINE (UNII: 1EQV5MLY3D)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRTRISODIUM HEDTA (UNII: K3E0U7O8KI)  
INGRWATER (UNII: 059QF0KO0R)  
INGR1-HYDROXYETHYL 4,5-DIAMINO PYRAZOLE SULFATE ()  
INGR4-AMINO-2-HYDROXYTOLUENE (UNII: UBB8XEB10B)  
INGRARGANIA SPINOSA KERNEL OIL ()  
INGRFRAGRANCE ()  
INGRP-AMINOPHENOL (UNII: R7P8FRP05V)  
INGRTOLUENE-2,5-DIAMINE (UNII: 24JO8Z0RJU)  
Labeler - Hoyu America Co.
Establishment
NameAddressID/FEIBusiness Operations
IDENTIPAK INC
Address:300 East Beech Ave.
City, State, Zip:McAllen, TX, 78501
Country:USA
3002422294

Revised: 2/2024
Document Id: 113b3555-7af0-f43d-e063-6394a90a3612
Set id: 10e470f0-643f-d2cd-e063-6294a90a258f
Version: 2
Effective Time: 20240212
 
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