NDC Code(s) : 15751-3030-2, 15751-3030-9, 15751-3030-6
Packager : Eminence Organic Skin Care Ltd.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne Advanced Clarifying HydratorSALICYLIC ACID CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15751-3030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE(UNII: V5VD430YW9)
CUCUMBER(UNII: YY7C30VXJT)
ROSA MOSCHATA OIL(UNII: J99W255AWF)
GRAPEFRUIT(UNII: O82C39RR8C)
SYMPHYTUM UPLANDICUM LEAF(UNII: D05HXK6R3G)
PEPPERMINT(UNII: V95R5KMY2B)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
BETA VULGARIS(UNII: 4G174V5051)
GLYCERIN(UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK(UNII: T7S323PKJS)
PROPANEDIOL(UNII: 5965N8W85T)
CITRUS MAXIMA FRUIT RIND OIL(UNII: 8U3877WD44)
SPEARMINT(UNII: J7I2T6IV1N)
SODIUM ACRYLATE(UNII: 7C98FKB43H)
OREGANO(UNII: 0E5AT8T16U)
THYME(UNII: CW657OBU4N)
CINNAMON(UNII: 5S29HWU6QB)
OLIVE OIL(UNII: 6UYK2W1W1E)
ROSEMARY(UNII: IJ67X351P9)
GOLDENSEAL(UNII: ZW3Z11D0JV)
LEMON(UNII: 24RS0A988O)
DEXPANTHENOL(UNII: 1O6C93RI7Z)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ISOHEXADECANE(UNII: 918X1OUF1E)
NIACIN(UNII: 2679MF687A)
ALLANTOIN(UNII: 344S277G0Z)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN(UNII: CQD833204Z)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARBUTIN(UNII: C5INA23HXF)
COCAMIDOPROPYL DIMETHYLAMINE(UNII: L36BM7DG2T)
SOYBEAN OIL(UNII: 241ATL177A)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SUNFLOWER OIL(UNII: 3W1JG795YI)
SORBIC ACID(UNII: X045WJ989B)
SODIUM POLYACRYLATE (2500000 MW)(UNII: 05I15JNI2J)
ACAI(UNII: 46AM2VJ0AW)
CARROT(UNII: L56Z1JK48B)
COCONUT(UNII: 3RT3536DHY)
STARCH, TAPIOCA(UNII: 24SC3U704I)
THIOCTIC ACID(UNII: 73Y7P0K73Y)
UBIDECARENONE(UNII: EJ27X76M46)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:15751-3030-21 in 1 BOX 09/01/2018
135 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:15751-3030-955 mL in 1 BOTTLE Type 0: Not a Combination Product09/01/2018
3NDC:15751-3030-63 mL in 1 PACKET Type 0: Not a Combination Product09/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 09/01/2018

LABELER - Eminence Organic Skin Care Ltd.(205753317)

PRINCIPAL DISPLAY PANEL

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Bottle

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