Skin & Scalp Lotion

Manufacturer
Albra Dewyn LLC
Effective date
2016-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:56

Label at a glance#

ProductSkin and Scalp Body
Active ingredientCOAL TAR
Label structure9 sections

Indications and uses

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

Dosage and administration

Shake well, for best result use twice daily or directed by doctor.

Label contents#

Full prescribing information#

Uses

OTC - PURPOSE SECTION

Controls symptoms of psoriasis, Atopic & Seborrheic Dermatitis & Dandruff.

Relieves itching, flaking, scaling & scalp irritation.

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Shake well, for best result use twice daily or directed by doctor.

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

Uses

INDICATIONS & USAGE SECTION

controls symptoms of:

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

Drug Fact

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

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

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

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

88

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59151-646-082020-01-31C16284748780-19d75b9cf-dd90-f424-e053-dadaa90a57ceSkin & Scalp Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59151-646-08Skin and Scalp Body237 mL in 1 BOTTLELOTION2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59151-646SKIN AND SCALP BODY (COAL TAR) LOTION [ALBRA DEWYN LLC]1Legacy NDC, 1 package rows20161108_40c0ea76-9f5b-3c8b-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59151-64659151-646-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
40c0ea76-9f5c-3c8b-e054-00144ff8d46c40c0ea76-9f5b-3c8b-e054-00144ff8d46c2016-09-01WarningsExact identifier
spl id: 40c0ea76-9f5c-3c8b-e054-00144ff8d46c
spl set id: 40c0ea76-9f5b-3c8b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.