NDC 51769-121 Silka Gel

Terbinafine Hydrochloride

NDC Product Code 51769-121

NDC 51769-121-30

Package Description: 30 g in 1 TUBE

NDC Product Information

Silka Gel with NDC 51769-121 is a a human over the counter drug product labeled by All Natural Dynamics. The generic name of Silka Gel is terbinafine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: All Natural Dynamics

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.

Silka Gel 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.

  • TERBINAFINE HYDROCHLORIDE 1 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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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: All Natural Dynamics
Labeler Code: 51769
FDA Application Number: ANDA077511 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 01-18-2021 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: 12-31-2022 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’.

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Silka Gel Product Label Images

Silka Gel 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

Distributed by:

PCGI Wholesale Chula Vista, CA, 91911

Active Ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • Cures most athletes foot (tinea pedis)cures most jock itch (tinea cruris) and ringworm (tinea corporis)relieves itching, burning, cracking and scaling which accompany this condition

Warnings

For external use only

Do Not Use

  • On nails or scalpin or near the mouth or eyesfor vaginal yeast infections

Otc - When Using

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if too much irritation occurs or gets worse

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

  • Adults and children 12 years and over:
  • Use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete’s foot: wear well-fitting, ventilated shoes. Change shoes and socks at least once daily
  • Between the toes only: apply twice a day (morning and night) for
  • 1 week or as directed by a doctor.
  • On bottom or sides of feet: apply twice a day (morning and night) for
  • 2 weeks or as directed by a doctor.
  • For jock itch and ringworm: apply twice a day (morning and night) for
  • 1 week or as directed by a doctor.
  • Wash hands after each usechildren under 12 years: ask a doctor

Other Information

  • Do not use if seal on tube is broken or is not visiblestore at controlled room temperature 20° to 25°C (68° to 77°F)see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

Questions?

Call
1 877 99 GENOM (43666)

* Please review the disclaimer below.