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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63347-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
XANTHAN GUM 
ALOE VERA LEAF 
GLYCERIN 
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 
ARCTIUM LAPPA ROOT 
TEA TREE OIL 
LAVENDER OIL 
CHAMAEMELUM NOBILE FLOWER 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63347-301-01112 g in 1 JAR
2NDC:63347-301-02224 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/2012
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIBusiness Operations
Blaine Labs Inc.017314571manufacture(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.