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.

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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:

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

Blaine EuCutaSol5 Label

EUCUTASOL 
coal tar cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-301
Route of Administration TOPICAL DEA Schedule     
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
2 NDC:63347-301-02 224 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 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)

Revised: 2/2013
Document Id: 2ecfeef1-8736-42e8-b6bf-80b77d8d14b3
Set id: da75a9c5-62ef-4dbb-becf-d343c41f6315
Version: 1
Effective Time: 20130212
 
Blaine Labs Inc.