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Skin and scalp by Albra Dewyn LLC

Medically reviewed on September 14, 2016

Dosage form: shampoo
Ingredients: COAL TAR 17mg in 1mL
Labeler: Albra Dewyn LLC
NDC Code: 59151-645

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.

Skin & Scalp Shampoo / Body Wash

DRUG FACTS

Active ingredients Purpose
Coal tar solution 8.5% v/v .......................................................................Psoriasis, Atopic & Seborrheic
(Equivalent to 1.7% Coal tar)............................................................................. Dermatitis & Dandruff

USES

Controls symptoms of Psoriasis, Atopic & Seborrheic Dermatitis & Dandruff. • Relieves itching, flaking, scaling, & scalp irritation.

WARNINGS


For external use only: Ask a doctor before use if your body has a condition that which covers a large part of the body. Keep out of reach of children. When using this product: Do not use for a prolonged period of time without consulting a doctor. Do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. 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. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Shake well, for best results use at least twice a week or directed by a doctor. For shampooing, wet hair thoroughly, massage shampoo into the scalp. Lather, leave on scalp for several minutes. Rinse and repeat. For body wash, add a small amount to damp wash cloth and wash the affected areas. Rinse and repeat

Controls symptoms of: • Seborrheic Dermatitis, • Psoriasis, • Minor & Severe Dandruff, • Relief of scalp & skin itching, irritation & flaking associated with Atopic Dermatitis

OTHER INFORMATION

In rare instances, discoloration of gray, blonde, bleached or tinted hair may occur.

INactive

Inactive ingredients Water, alcohol (5%), sodium lauryl sulfate, sodium laureth sulfate, cocamidopropyl betaine, eucalyptus oil,
cocamide DEA methylparaben, benzoic acid, propylparaben, PEG 150 Distearate, camphor, vitamin E acetate (DL-alpha-tocopheryl acetate),
vitamin A palmitate (Retinyl Palmitate), jojoba oil, menthol, vitamin H (biotin), polysorbate 80, fragrance, citric acid.

questions or comments

Questions or comments Toll free number: 1-855-458-2400, Fax: 1-972-228-2400 or info@albradewynllc.com

Uses • Controls symptoms of Psoriasis, Atopic & Seborrheic Dermatitis & Dandruff. • Relieves itching, flaking, scaling, & scalp irritation.

SKIN AND SCALP 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59151-645
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR17 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL 
COCAMIDOPROPYL DIMETHYLAMINE PROPIONATE 
PEG-150 DISTEARATE 
CAMPHOR (NATURAL) 
JOJOBA OIL 
BIOTIN 
POLYSORBATE 80 
WATER 
ALCOHOL 
SODIUM LAURYL SULFATE 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
METHYLPARABEN 
BENZOIC ACID 
PROPYLPARABEN 
MENTHOL 
CITRIC ACID MONOHYDRATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
VITAMIN A PALMITATE 
Packaging
#Item CodePackage Description
1NDC:59151-645-08237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/01/2016
Labeler - Albra Dewyn LLC (069451336)
Establishment
NameAddressID/FEIOperations
Albra Dewyn LLC069451336manufacture(59151-645)

 
Albra Dewyn LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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