NDC Code(s) : 70017-002-01
Packager : CLASSYS INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cluederm Aqua Solution Rejuve PlusHYALURONATE SODIUM LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70017-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
(HYALURONIC ACID - UNII:S270N0TRQY) 		HYALURONATE SODIUM20 mg in 500 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
SERICIN 1(UNII: N6466G03F7)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
HORSE CHESTNUT(UNII: 3C18L6RJAZ)
ROYAL JELLY(UNII: L497I37F0C)
MORUS ALBA BARK(UNII: 7O71A48NDP)
ASIAN GINSENG(UNII: CUQ3A77YXI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
AZADIRACHTA INDICA LEAF(UNII: HKY915780T)
AZADIRACHTA INDICA FLOWER(UNII: 3TE8A92UPM)
TURMERIC(UNII: 856YO1Z64F)
OAT KERNEL OIL(UNII: 3UVP41R77R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
PAPAIN(UNII: A236A06Y32)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
ECKLONIA CAVA(UNII: UXX2N5V39P)
CODIUM TOMENTOSUM(UNII: B8B45BRU87)
OCIMUM TENUIFLORUM LEAF OIL(UNII: KRP8S57T49)
ETHOHEXADIOL(UNII: M9JGK7U88V)
LEUCOJUM AESTIVUM BULB(UNII: 190M641M70)
HYACINTHUS ORIENTALIS WHOLE(UNII: 33J37WGZ7H)
ACETYL HEXAPEPTIDE-8(UNII: L4EL31FWIL)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CORALLINA OFFICINALIS(UNII: 4004498D06)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70017-002-01150 mL in 1 CONTAINER Type 0: Not a Combination Product28/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/28/2018

PRINCIPAL DISPLAY PANEL

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