NDC 66923-412 Maximum Strength Cold Sore Treatment

Maximum Strength Cold Sore Treatment

NDC Product Code 66923-412

NDC Code: 66923-412

Proprietary Name: Maximum Strength Cold Sore Treatment What 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: Maximum Strength Cold Sore Treatment What 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.

NDC Code Structure

  • 66923 - Ranir Llc
    • 66923-412 - Maximum Strength Cold Sore Treatment

NDC 66923-412-02

Package Description: 1 TUBE in 1 PACKAGE > 2 g in 1 TUBE

NDC Product Information

Maximum Strength Cold Sore Treatment with NDC 66923-412 is a a human over the counter drug product labeled by Ranir Llc. The generic name of Maximum Strength Cold Sore Treatment is maximum strength cold sore treatment. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ranir Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Maximum Strength Cold Sore Treatment 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.

  • MENTHOL 10 mg/g
  • PETROLATUM 892 mg/g
  • CAMPHOR (SYNTHETIC) 30 mg/g
  • PHENOL 15 mg/g

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.

  • TOCOPHEROL (UNII: R0ZB2556P8)
  • THYMOL (UNII: 3J50XA376E)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)

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: Ranir Llc
Labeler Code: 66923
FDA Application Number: part333E 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: 06-27-2019 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.

Maximum Strength Cold Sore Treatment Product Label Images

Maximum Strength Cold Sore Treatment 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

Active ingredients PurposeCamphor 3.00%Menthol 1.00%Phenol 1.50%White Petrolatum 89.20%

Otc - Purpose

PurposeCold sore/fever blister treatmentCold sore/fever blister treatmentCold sore/fever blister treatmentSkin Protectant

Otc - When Using

Uses• For treatment of cold sores/fever blisters on the face or lips• Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters• Temporarily protects minor cuts, scrapes, burns, and sores• Helps prevent and temporarily protects chapped or cracked skin and lips

Warnings

WarningsFor external use only: Do not use in the eyes or apply over large areas of the body. In case of deep orpuncture wounds, animal bites or serious burns, consult a physician.Allergy alert: Do not use if you are allergic to any of the ingredients in this product.When using this product avoid contact with eyes. Use only as directed.Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unlessdirected by a doctor.

Other Safety Information

Other information store at room temperature

Inactive Ingredient

Inactive ingredients Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol,Tocopheryl Nicotinate

Otc - Questions

Questions or comments?Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.Serious side effects associated with use of this product may be reported to this number.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right awayat 1-800-222-1222.

Indications & Usage

Directions• Clean the affected area • Apply a small amount of this product to the affected area 1 to 3 times daily• Rub in gently • May be covered with a sterile bandage • Wash hands before and after applying cream• Do not share this product with anyone • Children under 12 years of age: ask a doctor

Recent Major Changes

Indications and UsageSection added 06/26/2019Dosage and AdministrationSection added 06/26/2019

Dosage & Administration

Apply a small amount of this product to the affected area 1 to 3 times daily

Cold Sore Tube Card Pdp

  • Maximum Strength(Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%)Cold Sore TreatmentTemporary Relief of Pain and Discomfort!Works on ContactApplied ClearPhalate Free**Sulfate FreeParaben Free*With Tea Tree OilMedicatedCold Sore / Fever Blister treatment & Skin ProtectantNET WT 0.07 OZ ( 2.0 g)*Free from Methylparaben, Ethylparaben, Propylparaben and Butylparaben** Tested per CPSC-CH-C1001.09.3Distributed by:Ranir LLC4701 East Paris Ave SEGrand Rapids, MI 49512

* Please review the disclaimer below.

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