NDC Code(s) : 72394-000-00
Packager : Clean, Know What's On Your Skin LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CleanZINC OXIDE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72394-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION120 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
LEVOMENOL(UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CHAMOMILE(UNII: FGL3685T2X)
ORANGE(UNII: 5EVU04N5QU)
ORANGE PEEL(UNII: TI9T76XD44)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
ISODODECANE(UNII: A8289P68Y2)
EVENING PRIMROSE OIL(UNII: 3Q9L08K71N)
DULSE(UNII: 7832HOY4ZQ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPANEDIOL(UNII: 5965N8W85T)
ROSA CANINA FRUIT OIL(UNII: CR7307M3QZ)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TETRASODIUM GLUTAMATE DIACETATE(UNII: 5EHL50I4MY)
TOCOPHEROL(UNII: R0ZB2556P8)
TRILAURETH-4 PHOSPHATE(UNII: M96W2OLL2V)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72394-000-00100 mL in 1 TUBE Type 0: Not a Combination Product18/07/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/18/2018

LABELER - Clean, Know What's On Your Skin LLC(081544845)

PRINCIPAL DISPLAY PANEL

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