NDC 71229-101 Phytozine Ringworm Treatment Maximum Strength

Tolnaftate

NDC Product Code 71229-101

NDC Code: 71229-101

Proprietary Name: Phytozine Ringworm Treatment Maximum Strength 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: Tolnaftate 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
  • 71229 - The Sisquoc Healthcare Corporation
    • 71229-101 - Phytozine Ringworm Treatment

NDC 71229-101-11

Package Description: 28 g in 1 TUBE

NDC Product Information

Phytozine Ringworm Treatment Maximum Strength with NDC 71229-101 is a a human over the counter drug product labeled by The Sisquoc Healthcare Corporation. The generic name of Phytozine Ringworm Treatment Maximum Strength is tolnaftate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: The Sisquoc Healthcare Corporation

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.


Phytozine Ringworm Treatment Maximum Strength 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.

  • TOLNAFTATE 1 g/100g

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.

  • WATER (UNII: 059QF0KO0R)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
  • TRIDECETH-6 (UNII: 3T5PCR2H0C)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • OLETH-10 PHOSPHATE (UNII: Q95361F4VS)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OAT (UNII: Z6J799EAJK)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • MENTHOL (UNII: L7T10EIP3A)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)
  • JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD)
  • CLOVE LEAF OIL (UNII: VCA5491KVF)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: The Sisquoc Healthcare Corporation
Labeler Code: 71229
FDA Application Number: part333C 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: 03-25-2019 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.

Phytozine Ringworm Treatment Maximum Strength Product Label Images

Phytozine Ringworm Treatment 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

Active Ingredient

TOLNAFTATE 1%

Purpose

ANTIFUNGAL

Uses

  • CURES MOST RINGWORMRELIEVES ITCHING, REDNESS, IRRITATION AND DISCOMFORT WHICH ACCOMPANY THIS CONDITION.

Warnings

  • FOR EXTERNAL USE ONLY.WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES.STOP USE AND ASK A DOCTOR IFIRRITATION OCCURSTHERE IS NO IMPROVEMENT WITHIN 4 WEEKS.DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

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 AWAY.

Directions

  • For the cure of most ringworm (tinea corporis) and athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.Wash affected area and dry thoroughly. Apply a layer of PHYTOZINE over the affected area twice daily (morning and night). Allow the cream to dry for at least 3 minutes before covering the affectedarea with clothing.Wash hands after each application to preventthe chance of the infection spreading to other parts of the skin.Most ringworm infections will require between 3-4 weeks of continuous daily treatment before the infection is completely eliminated.Proper use of PHYTOZINE will eliminate most ringworm infections. If the condition persists longer, contact a physician or medical professional.

Inactive Ingredients

Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polysorbate-20, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Glyceryl Stearate, PEG-100, Stearate, Propylene Glycol, Cetyl Alcohol, Oleth-10 Phosphate, Glycerin, Avena (Oat), Kernel Extract, Aloe Barbadensis Leaf Juice, Actrostaphylos Uva Ursi Leaf Extract, Propolis Extract, Theobroma Cacao(Cocoa) Seed Butter, Rosa Canina Fruit Oil, Camphor, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, LavandulaAngustifolia (Lavender) Oil, Jasminum Of����icinale (Jasmine) Oil, Eugenia Caryophyllus (Clove) Leaf Oil, TocopherylAcetate, Stearic Acid, Propylene Glycol, Butylene Glycol, Cetyl Hydroxyethylcellulose, Sodium Hydroxide, Phenoxyethanol , Ethylhexylglycerin

Other Safety Information

Store between 20°c to 25°C (68° to 77°F)

* Please review the disclaimer below.

Previous Code
71227-001
Next Code
71230-001