Otc - Purpose
Acne Treatment Cream
Pure Nerium Acne Therapy
FDA Label NDC 72216-227
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nerium Skincare, Inc. for the product Pure Nerium Acne Therapy (NDC 72216-227). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, otc - active ingredient, indications & usage, warnings, otc - when using, otc - keep out of reach of children, instructions for use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - When Using
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.
Otc - Keep Out Of Reach Of Children
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
Otc - 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.
30.3g/1.07fl.oz. (Pn Acne 30ml Contour Bottle Carton Us Otc Cdw Pv4rz)
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