NDC 72216-226 Neriumrx Acne Therapy

Salicylic Acid 2.0%

NDC Product Code 72216-226

NDC Code: 72216-226

Proprietary Name: Neriumrx Acne Therapy Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid 2.0% Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 72216 - Nerium Skincare, Inc.
    • 72216-226 - Neriumrx Acne Therapy

NDC 72216-226-11

Package Description: 1 TUBE in 1 CARTON > 100 mL in 1 TUBE (72216-226-10)

NDC 72216-226-31

Package Description: 1 TUBE in 1 CARTON > 30 mL in 1 TUBE (72216-226-03)

NDC Product Information

Neriumrx Acne Therapy with NDC 72216-226 is a a human over the counter drug product labeled by Nerium Skincare, Inc.. The generic name of Neriumrx Acne Therapy is salicylic acid 2.0%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nerium Skincare, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Neriumrx Acne Therapy Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SALICYLIC ACID 2 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • 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)
  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nerium Skincare, Inc.
Labeler Code: 72216
FDA Application Number: part333D Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-28-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Neriumrx Acne Therapy Product Label Images

Neriumrx Acne Therapy Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Salicylic acid 2.0%.

Otc - Purpose

Acne Treatment Cream

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

* Please review the disclaimer below.

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