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.

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Dermabon Psoriasis and Dandruff Soap

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 Label2

DERMABON PSORIASIS AND DANDRUFF
coal tar soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49758-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	2.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM BORATE (UNII: 91MBZ8H3QO)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
STEARIC ACID (UNII: 4ELV7Z65AP)
PETROLATUM (UNII: 4T6H12BN9U)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49758-100-10	90 g in 1 PACKAGE; Type 0: Not a Combination Product	10/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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: 4/2021

Document Id: c13340d1-ed67-afb2-e053-2995a90abb1a

Set id: 74bb470a-6b72-40ca-b60b-c8c59b64841b

Version: 9

Effective Time: 20210430

Dermabon de Chihuahua, S. de R.L. de C.V.