OTC Medication Information: Dermabon Psoriasis and Dandruff

DERMABON PSORIASIS AND DANDRUFF- coal tar soap
Dermabon de Chihuahua, S. de R.L. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients

Coal Tar 2.13%

Purpose

Anti-psoriasis, Anti-dandruff

Uses

For the relief of dandruff and psoriasis

Warnings

  • For external use only.
  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
  • If condition worsens or does not improve after regular use of this product as directed, consult a doctor.
  • 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.

Do not use

  • for prolonged periods without consulting a doctor.
  • Do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.
  • If condition covers a large area of the body, consult your doctor before using this product.

Keep out of the reach of children

Directions

Use on affected areas in place of your regular soap.

Inactive Ingredients

Borax, Ethyl Alcohol, Glycerin, Glyceryl Stearate, Lanolin, Metil Paraben, Sodium Hypochlorite, Stearic Acid, Petrolatum Oil, Vitamin E, Soap base and Water.

Package Labeling:

Label0
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Label2
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DERMABON PSORIASIS AND DANDRUFF
coal tar soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49758-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COAL TAR (COAL TAR) COAL TAR 2.13 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SODIUM BORATE
ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
LANOLIN
METHYLPARABEN
SODIUM HYPOCHLORITE
STEARIC ACID
PETROLATUM
ALPHA-TOCOPHEROL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49758-100-10 90 g in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 10/01/2009
Labeler — Dermabon de Chihuahua, S. de R.L. de C.V. (951580110)
Registrant — Dermabon de Chihuahua, S. de R.L. de C.V. (951580110)

Revised: 04/2021 Dermabon de Chihuahua, S. de R.L. de C.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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