EUCUTASOL - coal tar cream
Blaine Labs Inc.

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.

----------

Active Ingredients

Active Ingredient Coal Tar (2%)

Purpose

Purpose Psoriasis/Sebhorreic Dermatitis Treatment

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.

Uses

For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including:

Itching, scaling, flaking, redness and irritation of the skin
Treats eczema
Helps prevent recurrence

Warnings

For external use only.

Directions

Apply to affected areas as directed by a doctor.

Ask a Doctor

Ask a doctor before use

If condition covers a large area of the body,around the rectum, in the genital area or the groin. Also, if needed for prolonged periods, or with other forms of psoriasis therapy such as ultra violet radiation or prescription drugs.

Inactive Ingredients

Other

Colloidal Silver, Dimethicone, Hydrocortisone

Inactive Ingredients

Water, Xanthan Gum, Aloe Vera, Glycerin, Propylene Glycol, Safflower Oil, Dimethicone, C12/15 Alkyl Benzoate, Emulsifying Wax, Glycerol Stearate, Peg 100, Stearate, Cetyl Alcohol, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Hydrocortisone, Triethanolamine, Colloidal Silver, Burdock Root, Tea Tree Oil, Lavender Oil, Chamomile Extract. F,D,and C Yellow # 5

Package Label

EuCutaSol

PHYSICIAN FORMULA PSORIASIS TREATMENT Rx

With Colloidal Silver

NET WT. 4.0 oz. (112 gr.)

NDC: 63347-330-01

BlaineLabs (800) 307-8818 info@BlaineLabs.com Santa Fe Springs, CA 90670

EUCUTASOL
coal tar cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63347-300
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (COAL TAR)	COAL TAR	2 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
XANTHAN GUM
ALOE VERA LEAF
PROPYLENE GLYCOL
SAFFLOWER OIL
DIMETHICONE
ALKYL (C12-15) BENZOATE
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
CETYL ALCOHOL
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)
C13-14 ISOPARAFFIN
LAURETH-7
HYDROCORTISONE
TROLAMINE
SILVER
ARCTIUM LAPPA ROOT
TEA TREE OIL
LAVENDER OIL
CHAMAEMELUM NOBILE FLOWER
FD&C YELLOW NO. 5
GLYCERIN

Packaging
#	Item Code	Package Description
1	NDC:63347-300-01	112 g in 1 JAR
2	NDC:63347-300-02	224 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/17/2012	02/11/2013

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-300)

Revised: 02/2013

Document Id: 671c7f10-2531-4d79-b50e-ca751f302a66

Set id: 834ff580-0458-4b47-aaad-63bd31d363a2

Version: 2

Effective Time: 20130211

Blaine Labs Inc.