EUCUTASOL- coal tar cream

EuCutaSol by

Drug Labeling and Warnings

EuCutaSol by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

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

Warnings

For external use only.

Ask a doctor before use

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.

Directions

Directions

Apply to affected areas as directed by a doctor.

Other Inactive Ingredients

Other

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, Burdock Root, Tea Tree Oil, Lavender Oil, Chamomile Extract. F,D,and C Yellow # 5

Product label

EuCutaSol

PHYSICIAN FORMULA PSORIASIS TREATMENT Rx

NET WT. 4.0 oz. (112 gr.)

NDC: 63347-301-01

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

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INGREDIENTS AND APPEARANCE

EUCUTASOL 
coal tar cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
HYDROCORTISONE (UNII: WI4X0X7BPJ)
TROLAMINE (UNII: 9O3K93S3TK)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
TEA TREE OIL (UNII: VIF565UC2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-301-01	112 g in 1 JAR; Type 0: Not a Combination Product	07/01/2012
2	NDC: 63347-301-02	224 g in 1 JAR; Type 0: Not a Combination Product	07/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/01/2012

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-301)