NDC 72216-263 Neriumrx Cold Sore Therapy

Camphor 2%

NDC Product Code 72216-263

NDC 72216-263-62

Package Description: 1 BLISTER PACK in 1 CARTON > 2.5 g in 1 BLISTER PACK (72216-263-61)

NDC Product Information

Neriumrx Cold Sore Therapy with NDC 72216-263 is a a human over the counter drug product labeled by Nerium Skincare, Inc.. The generic name of Neriumrx Cold Sore Therapy is camphor 2%. 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 What 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 Cold Sore Therapy Active Ingredient(s)

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

  • CAMPHOR (NATURAL) 2 g/100g

Inactive Ingredient(s)

About 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.

  • LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • LINSEED OIL (UNII: 84XB4DV00W)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)
  • NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • EGG SHELL MEMBRANE (UNII: N7QBR4212V)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • SUCROSE COCOATE (UNII: 3H18P0UK73)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • ALLANTOIN (UNII: 344S277G0Z)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

Administration Route(s)

What 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

What 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: part348 What 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What 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: 09-19-2019 What 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 What 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 What 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 Cold Sore 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

Camphor 2%

Otc - Purpose

Fever Blister/Cold Sore Treatment

Indications & Usage

● For the temporary relief of pain and itching associated with cold sores.

Warnings

For external use only.

Other Safety Information

Avoid contact with the eyes.

Otc - Ask Doctor

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Otc - Keep Out Of Reach Of Children

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

Instructions For Use

● Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician

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 (NAE-8®), Docosanol, Glycerin, Cocos Nucifera (Coconut) Oil, Arachidyl Alcohol, Cetearyl Olivate, Hydrolyzed Egg Shell Membrane (Peptide Matrix – Collagen & Elastin), Olea Europaea (Olive) Fruit Oil, Water (Aqua), Sorbitan Olivate, Sucrose Cocoate, Dimethicone, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Glyceryl Caprylate, Arachidyl Glucoside, Pelargonium Graveolens (Geranium) Flower Oil, Allantoin, Leuconostoc/Radish Root Ferment Filtrate, Xanthan Gum, Potassium Sorbate, Carrageenan, Benzyl Alcohol, Ascorbyl Palmitate, Dipotassium Glycyrrhizate, Glyceryl Undecylenate, Lysine HCL, Olea Europaea (Olive) Leaf Extract.

Otc - Questions

1-(866)-535-5888
M-F (9am to 5 pm CST)

Dosage & Administration

2% Topical Cream

* Please review the disclaimer below.