SKIN AND SCALP- coal tar shampoo 
Albra Dewyn LLC

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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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.

8 oZ

SKIN AND SCALP 
coal tar shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59151-645
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR17 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
COCAMIDOPROPYL DIMETHYLAMINE PROPIONATE (UNII: 83750MLC4A)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
JOJOBA OIL (UNII: 724GKU717M)  
BIOTIN (UNII: 6SO6U10H04)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MENTHOL (UNII: L7T10EIP3A)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59151-645-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/01/2016
Labeler - Albra Dewyn LLC (069451336)
Establishment
NameAddressID/FEIBusiness Operations
Albra Dewyn LLC069451336manufacture(59151-645)

Revised: 9/2016
Document Id: 3c4a53a1-c856-382d-e054-00144ff88e88
Set id: 3c4a53a1-c855-382d-e054-00144ff88e88
Version: 1
Effective Time: 20160914
 
Albra Dewyn LLC