NDC 63347-503 Tineacide Antifungal Maximum Strength

Miconazole Nitrate

NDC Product Code 63347-503

NDC 63347-503-01

Package Description: 1 BOTTLE in 1 BOX > 35 g in 1 BOTTLE

NDC Product Information

Tineacide Antifungal Maximum Strength with NDC 63347-503 is a a human over the counter drug product labeled by Blaine Labs Inc.. The generic name of Tineacide Antifungal Maximum Strength is miconazole nitrate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Blaine Labs 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.

Tineacide Antifungal Maximum Strength 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.

  • MICONAZOLE NITRATE .7 g/35g

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.

  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • UREA (UNII: 8W8T17847W)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CLOTRIMAZOLE (UNII: G07GZ97H65)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • OREGANO LEAF OIL (UNII: 7D0CGR40U1)
  • OLIVE OIL (UNII: 6UYK2W1W1E)

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: Blaine Labs Inc.
Labeler Code: 63347
FDA Application Number: part333C 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2019 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.

Tineacide Antifungal Maximum Strength 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

Other

Drug Facts

Otc - Active Ingredient

Active IngredientMiconazole Nitrate 2%

Otc - Purpose

PurposeAntifungal

Indications & Usage

Uses• Cures most athlete’s foot (tinea pedis).• Cures most jock itch (tinea cruris) and ringworm (tinea corporis).• Relieves discomfort, irritation, cracking, scaly skin between the   toes and itching, burning feet.

Warnings

Warnings• Do not use on children under 2 years of age unless directed by a   physician.• For external use only.• Do not use for vaginal yeast infections.• Avoid contact with the eyes. If eye contact occurs, rinse thoroughly  with water.If irritation occurs or if there is no improvement within 4 weeks(for athlete’s foot or ringworm) or within 2 weeks (for jock itch),discontinue use and consult a physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away at 800.222.1222

Dosage & Administration

Directions• Wash the affected area with soap and water and dry thoroughly.• Apply a thin layer of the product over affected area twice daily  (morning and night) or as directed by a physician.  Supervise children in the use of this product.• For athlete’s foot: Pay special attention to spaces between the  toes; wear well-fitting, ventilated shoes, and change shoes and  socks at least once daily.• For athlete’s foot and ringworm: Use daily for 4 weeks; for jock  itch, use daily for 2 weeks. If condition persists longer, consult  a doctor.• This product is not effective on the scalp or nails.• Wash hands after each use.

Other Safety Information

Other Information• Do not use if seal on bottle is broken or is not visible.• Store between 2˚ and 30˚ C (36˚ and 86˚ F).

Inactive Ingredient

Inactive IngredientsWater (aqua), Cetyl Alcohol, PEG 100 Stearate, Glyceryl Stearate, StearicAcid, Coco-Caprylate/Caprate, Polysorbate 60, Triethanolamine, Urea,Hydroxyethylcellulose, Disodium EDTA, Methylparaben, Propylparaben,Lavandula Angustifolia Lavender Oil, Tea Tree Oil, Clortrimazole, Aloe,Barbadensis Leaf Juice, Origanum Vulgare Leaf Oil (content carvacrol),Olea Europaea (Olive) Fruit Oil

Principal Display Package

Dr. Blaine's®TINEACIDE+®ANTIFUNGAL CREAMMONEY BACK100%GUARANTEEDr. Blaine's®TINEACIDE+®ANTIFUNGAL CREAMMAXIMUMSTRENGTHFUNGUS TREATMENT1.25 OZ (36.9mg)6 16728 00004  0Dr. Robert Blaine developedTineacide® Antifungal Cream in 1995because he suffered the loss of hisfoster father due to complicationsfrom diabetes and fungal footinfection. Dr. Blaine chose todevote his career to podiatry and properfoot care. 25 years later, Tineacide®has become synonymous withantifungal foot care products thatactually work to kill foot fungus.To see Dr. Blaine’s full story, go toTINEACIDE.comQuestions or Comments? Call 800.307.8818 Monday - Friday,8:00 AM and 5 PM (PST)All rights reserved. Made in the U.S.A.Please recycle.TINEACIDE+®ANTIFUNGAL CREAMADVANCEDFORMULATIONNOW CONTAINING CARVACROLWILL ELIMINATE YOUR FOOTFUNGUS OR WE WILL REFUND YOURMONEY IF IT DOESN’T WORKFOR YOU!• ELIMINATES ODORS• KILLS THE SKIN FUNGUS   THAT CAUSES FUNGAL   NAILS• TREATS MILD TO SEVERE   INFECTIONS• MEDICAL GRADE   ADVANCED FORMULA• 100% MONEY-BACK   GUARANTEE!Manufactured by: Blaine Labs, Inc.11307 Lockport PlaceSanta Fe Springs, CA 90670800.307.8818 | www.TINEACIDE.com05001-01                        REV 20190326res

* Please review the disclaimer below.

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