ACNE DEFENSE FOAMING CLEANSER MERLE NORMAN- salicylic acid liquid

Acne Defense Foaming Cleanser by

Drug Labeling and Warnings

Acne Defense Foaming Cleanser by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active (medicinal) ingredient                             Purpose

​Salicylic Acid 2.0% ..............................................  Acne Treatment

PURPOSE

For the treatment of acne

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away. 

INDICATIONS & USAGE

Using other topical acne medication at the same time or immediately followign the use of this product may increase dryness or irritation of the skin. If this occurrs, only one medication should be used unless directed by a doctor

WARNINGS

​Warning

• ​For external use only
• ​Keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

Massage product into lather and apply onto damp face, avoiding eye area. Rinse thoroughly. Wash 2 to 3 times daily or as directed by a doctor. If bothersome drynesss or peeling occurs, reduce application to once a day or every other day. 

INACTIVE INGREDIENT

Aqua/Water/Eau, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, Disodium Cocoamphodiacetate, Acacia Concinna Fruit Extract, Aloe Barbedensis Leaf Juice, Gypsophila Pariculata Root Extract, Chrysanthemum Parthenium (Feverfew) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sea Whip Extract, Chamomila Recutita (Matricaria) Flower Extract, Elettaria Cadamomum Seed Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Eugenia Caryophyllus (Clove) Flower Extract, Gardenia Aitensis Flower Extract, Hibiscus Abelmoschus Seed Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Vanilla Planifolia Fruit Extract, Hedychium Spicatum Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Plumeria Rubra Flower Extract, Ascorbyl Palmitate, Retinyl Plamitate, Tocopheryl Acetate, Cocamidopropyl PG-Dimonium Chloride Phosphate, PEG-9 Dimethicone, Phospholipids, Glucose, Lactic Acid, Caprylic/Capric Triglyceride, Panthenol, Balanites Aegyptiace Fruit Extract, Bisabolo, Ethoxydiglycol, Propylene Glycol, Xanthan Gum, Disodium EDTA

PRINCIPAL DISPLAY PANEL

ACNE DEFENSE FOAMING CLEANSER

merle norman

LIQUID

135 mL e  4.5 FL. OZ.

INGREDIENTS AND APPEARANCE

ACNE DEFENSE FOAMING CLEANSER  MERLE NORMAN
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
ACACIA CONCINNA FRUIT (UNII: S9108H4YLE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GYPSOPHILA PANICULATA ROOT (UNII: RH6WI83A9M)
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)
ORANGE (UNII: 5EVU04N5QU)
CUCUMBER (UNII: YY7C30VXJT)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
CHAMOMILE (UNII: FGL3685T2X)
CARDAMOM (UNII: 8BC4CUT4JL)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
ORANGE PEEL (UNII: TI9T76XD44)
CLOVE (UNII: K48IKT5321)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
APRICOT (UNII: 269CJD5GZ9)
APPLE (UNII: B423VGH5S9)
VANILLA (UNII: Q74T35078H)
HEDYCHIUM SPICATUM ROOT (UNII: 1831B6Y350)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-9 DIMETHICONE (UNII: 9OZ27X065D)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
LACTIC ACID (UNII: 33X04XA5AT)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PANTHENOL (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-200-01	135 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/13/2017

Labeler - Merle Norman Cosmetics, Inc (008479388)

Registrant - Merle Norman Cosmetics, Inc (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc		008479388	manufacture(57627-200)