PURE NERIUM ACNE THERAPY- salicylic acid 2.0% cream

PURE NERIUM ACNE THERAPY by

Drug Labeling and Warnings

PURE NERIUM ACNE THERAPY by is a Otc medication manufactured, distributed, or labeled by Nerium SkinCare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Acne Treatment Cream

ACTIVE INGREDIENT

Salicylic acid 2.0%.

INDICATIONS & USAGE

For the treatment of acne.
Dries and clears acne blemishes, acne pimples, blackheads, whiteheads and allows skin to heal.
Penetrates pores to control acne blemishes, acne pimples, blackheads, whiteheads.
Helps keep skin clear of new acne blemishes, acne pimples, blackheads, whiteheads.

WARNINGS

For external use only.​

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE

Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer one to three times daily.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Sensitivity Test for a New User. Apply product sparingly to one or two small affected ares during the first 3 days. If no discomfort occurs, follow the directions stated above.

OTHER SAFETY INFORMATION

Not recommended for use by pregnant or nursing women.

STORAGE AND HANDLING

Transport and store in a cool dry place and keep away from direct sunlight.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Nerium Oleander Leaf Extract (NAE8®), Water (Aqua), Propanediol, Hydrolyzed Egg Shell Membrane (Peptide Matrix – Collagen & Elastin), Cetyl Alcohol, Glycerin, Glyceryl Stearate, Potassium Cetyl Phosphate, Cetearyl Olivate, Caprylic/Capric Triglyceride, Dimethicone, Ricinus Communis (Castor) Seed Oil, Glyceryl Caprylate, Sorbitan Olivate, Lysolecithin, Sclerotium Gum, Xanthan Gum, Allantoin, Arginine, Avena Sativa Kernel Flour (Colloidal Oatmeal), Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Pelargonium Graveolens (Geranium) Flower Oil, Tocopherol, Fragrance, Leuconostoc/Radish Root Ferment Filtrate, Pullulan, Ocimum Basilicum (Basil) Extract, Linum Usitatissimum (Linseed) Seed Oil, Carum Petroselinum (Parsley) Extract, Benzyl Alcohol, Potassium Sorbate, Dipotassium Glycyrrhizate, Glyceryl Undecylenate, Sea Salt, Mahonia Aquifolium (Oregon Grape) Root Extract, Sodium Benzoate, Muriella Aurantiaca/Ruttnera Lamellosa Oil (Plankton Extract), Citric Acid, Lecithin

QUESTIONS

1-(844)-599-7787 M-F (9 am to 5 pm CST)

DOSAGE & ADMINISTRATION

2% Topical Cream

Principal Display Panel

PURE
NERIUM®

ACNE
THERAPY CREAM
WITH SALICYLIC ACID

PATENTED
NERIUM ALOE
EXTRACT

NAE-8®

PURE NERIUM® -ACNE THERAPY CREAM, 30.3g/1.07 FL.OZ.

INGREDIENTS AND APPEARANCE

PURE NERIUM ACNE THERAPY 
salicylic acid 2.0% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72216-227
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 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
PULLULAN (UNII: 8ZQ0AYU1TT)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)
WATER (UNII: 059QF0KO0R)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
XANTHAN GUM (UNII: TTV12P4NEE)
OATMEAL (UNII: 8PI54V663Y)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)
PROPANEDIOL (UNII: 5965N8W85T)
LINSEED OIL (UNII: 84XB4DV00W)
PARSLEY (UNII: 58FMD0Q0EV)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SEA SALT (UNII: 87GE52P74G)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN OLIVATE (UNII: MDL271E3GR)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
ALLANTOIN (UNII: 344S277G0Z)
ARGININE (UNII: 94ZLA3W45F)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72216-227-32	1 in 1 CARTON	09/16/2019
1	NDC: 72216-227-13	30.3 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/28/2019

Labeler - Nerium SkinCare, Inc. (859420916)

Registrant - Nerium SkinCare, Inc. (859420916)