Scytera
FDA Label NDC 63094-0801

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dpt Laboratories, Ltd. for the product Scytera (NDC 63094-0801). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, active ingredient - purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Scytera™ Foam is an emollient foam containing 10% coal tar topical solution (Liquor Carbonis Detergens) equivalent to 2% coal tar.

Active Ingredient - Purpose

Active ingredient: Coal Tar 2% (from Coal Tar Topical Solution USP, 10%) Purpose: Psoriasis

Use

For relief of the symptoms of psoriasis.

Warnings

For external use only. FlammableAvoid fire, flame, or smoking during and immediately following application.
WarningThis product contains chemicals known to the state of California to cause cancer.Patent PendingMade in USA. Marketed by:Promius Pharma, LLC Bridgewater, NJ 08807 Under license from Foamix LTD, Israel

Do Not Use

  • for prolonged periods without consulting a doctor
  • this product in or around the rectum or in the genital area or groin except on the advice of a doctor

Ask A Doctor Before Use If You Have

A condition that covers a large area of your body.

Ask A Doctor Or Pharmacist Before Use If You Are

Using the product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.

When Using This Product

  • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
  • use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
  • product can stain clothing, contact lenses, and hair. To minimize staining, allow product to dry before contact.

Stop Use And Ask Doctor If

Condition worsens or does not improve after regular use of this product as directed.

If Pregnant Or Breastfeeding

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions

  • shake the can well before use.
  • invert the can to dispense. Upright dispensing will cause loss of propellant.
  • apply to affected areas one to four times daily or as directed by a doctor.

Other Information

  • contents under pressure. Do not puncture or incinerate.
  • store at 68°F to 77°F (20°C to 25°C)
  • do not expose to heat or store at temperatures above 120°F (49°C)

Inactive Ingredients

Caprylic/capric triglyceride, ceteareth 20, citric acid, cyclomethicone, dimethicone, EDTA disodium, glycerin, hydroxypropyl methyl cellulose, isopropyl myristate, peppermint oil, phenoxyethanol, potassium sorbate, purified water, sodium citrate, stearic acid, xanthan gum, hydrocarbon (propane/butane) propellant.

Questions?

1-888-966-8766

Scytera™ (Coal Tar)Foam 2%, 100 G

Carton and Can LabelNDC 67857-801-52Psoriasis FoamScytera™ (Coal Tar) Foam 2%Promius Pharma™NET WT. 3.3 oz (100 g)Carton (California)NDC 67857-801-26Psoriasis FoamScytera™ (Coal Tar) Foam 2%Promius Pharma™NET WT. 3.3 oz (100 g)

Scytera™ (Coal Tar)Foam 2%, 12 G Sample Size

Packer (Box)Available in 100 g CansScytera™ (Coal Tar) Foam 2%Promius Pharma™Professional SamplesNet Quantity 12 x 12 g CansNDC 67857-801-12Packer (Box) (California)Available in 100 g CansScytera™ (Coal Tar) Foam 2%Promius Pharma™Professional SamplesNet Quantity 12 x 12 g CansNDC 67857-801-19Can LabelNDC 67857-801-12 Psoriasis Foam Scytera™ (Coal Tar) Foam 2%SAMPLE, NOT FOR SALENET WT. 0.4 oz (12 g)

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