NDC Code(s) : 15751-3020-2, 15751-3020-4, 15751-3020-6
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 MasqueSALICYLIC ACID CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15751-3020
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 ACID5 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)
SOYBEAN OIL(UNII: 241ATL177A)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SUNFLOWER OIL(UNII: 3W1JG795YI)
SORBIC ACID(UNII: X045WJ989B)
SODIUM POLYACRYLATE (2500000 MW)(UNII: 05I15JNI2J)
SPEARMINT(UNII: J7I2T6IV1N)
COCAMIDOPROPYL DIMETHYLAMINE(UNII: L36BM7DG2T)
SULFUR(UNII: 70FD1KFU70)
BASIL OIL(UNII: Z129UMU8LE)
XANTHAN GUM(UNII: TTV12P4NEE)
MONTMORILLONITE(UNII: A585MN1H2L)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
POLYSORBATE 20(UNII: 7T1F30V5YH)
EUCALYPTUS OIL(UNII: 2R04ONI662)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
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:15751-3020-21 in 1 BOX 09/01/2018
160 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:15751-3020-4120 mL in 1 TUBE Type 0: Not a Combination Product09/01/2018
3NDC:15751-3020-63 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)

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