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Skin and Scalp Body by Albra Dewyn LLC

Medically reviewed on October 11, 2016

Dosage form: lotion
Ingredients: COAL TAR 0.5mg in 1mL
Labeler: Albra Dewyn LLC
NDC Code: 59151-646

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 Lotion

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 convers 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 ultrviolet radiation or prescription drugs unless directed by a doctor. Avoid contact with eyes. if contact occurs, rinse eys thoroughly with water. Use cation in exposing skin to sunlght after applying this product. It may increase your tendecy 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 result use twice daily or directed by doctor.

Other Information

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

Inactive Ingredients

Purified water, glycerin (from coconut oil), stearic acid (from coconut oil), pure plant oil complex (soy & jojoba oils), cetylpalmitate (from palm oil), eucalyptus oil, cetearyl alcohol (from palm oil), poly sorbate (from palm oil), glyceryl stearate (from vegetable sources), cetyl alcohol (from palm oil), aminodimethicone (from silica), phenoxyethanol and ethylhexylglycerin (preservative complex from plant source), camphor, menthol, methylparaben, benzoic acid, propylparaben, PEG 150 distearate, vitamin E acetate (DL-alpha-tocopheryl acetate), vitamin A palmitate (Retinyl Palmitate), vitamin H (biotin), polysorbate 80, citric acid.

Question or Comments

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

Uses

controls symptoms of:

  • Seborrheic Dermatitis
  • Psoriasis
  • Minor & severe dandruff
  • relief of sclap & skin itching, irritation & flaking associated with Atopic Dermatiti

Drug Fact

Active Ingredients Purpose

Coal tar solution 1.7% v/v..........................................................................Psoriasis, Atopic & seborrheic

(equivalent to 0.5% coal tar)...................................................................................Dermatitis & Dandruff

label

SKIN AND SCALP BODY 
coal tar lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59151-646
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
PEG-150 DISTEARATE 
BIOTIN 
CITRIC ACID MONOHYDRATE 
WATER 
ETHYLHEXYLGLYCERIN 
PROPYLPARABEN 
PHENOXYETHANOL 
MENTHOL 
METHYLPARABEN 
BENZOIC ACID 
.ALPHA.-TOCOPHEROL ACETATE, D- 
VITAMIN A PALMITATE 
GLYCERIN 
SOYBEAN OIL 
CETYL PALMITATE 
EUCALYPTUS OIL 
CETYL ALCOHOL 
AMODIMETHICONE (800 CST) 
STEARIC ACID 
JOJOBA OIL 
POLYSORBATE 80 
GLYCERYL MONOSTEARATE 
Packaging
#Item CodePackage Description
1NDC:59151-646-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/03/2016
Labeler - Albra Dewyn LLC (069451336)
Establishment
NameAddressID/FEIOperations
Albra Dewyn LLC069451336manufacture(59151-646)

 
Albra Dewyn LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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