FDA.reportPublic FDA data

Advanced Acne Wash

Manufacturer
Elorac, Inc.
Effective date
2015-10-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:43:48

Label at a glance#

ProductAdvanced Acne Wash
Active ingredientBENZOYL PEROXIDE
Label structure16 sections

Indications and uses

For the treatment of acne

Dosage and administration

Wet face Apply to hands then work into a lather and massage gently onto face Rinse thoroughly and pat dry Because excessive drying of the skin may occur, start with one application daily, then increase to 2 times daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce usage to once a day or every other day If going outside, apply sunscreen after using this product. If irritation ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Continous Action for Lasting Results

4.4% Benzoyl Peroxide

Dermatologist Developed

OTC - ACTIVE INGREDIENT SECTION

​Drug Facts

​Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 4.4%

​Purpose

OTC - PURPOSE SECTION

Acne treatment

​Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

​Warnings

WARNINGS SECTION

For external use only

​Do not use if you

OTC - DO NOT USE SECTION

have very sensitive skin

are sensitive to benzoyl peroxide

​When using this product

OTC - WHEN USING SECTION

Avoid unnecessary sun exposure and use a sunscreen

Avoid contact with eyes, lips, and mouth

Avoid contact with hair and dyed fabrics, which may be bleached by this product

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently.

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

​Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation becomes severe

​Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

​Directions

DOSAGE & ADMINISTRATION SECTION

Wet face

Apply to hands then work into a lather and massage gently onto face

Rinse thoroughly and pat dry

Because excessive drying of the skin may occur, start with one application daily, then increase to 2 times daily if needed or as directed by a doctor

If bothersome dryness or peeling occurs, reduce usage to once a day or every other day

If going outside, apply sunscreen after using this product.

If irritation or sensitivity develops, stop use of both products and ask a doctor.

​Other information

OTHER SAFETY INFORMATION

THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS

KEEP TIGHTLY CLOSED

Avoid storing at temperatures above 100°F (38°C)

​Inactive ingredients

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cocamidopropyl Betaine, Ethylhexylglycerin, Euphorbia Cerifera (Candelilla) Wax, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Laureth-7, Phenoxyethanol, Polyacrylamide, Water

Questions?

OTC - QUESTIONS SECTION

1-847-362-8200 MON - FRI 9 AM - 5 PM (CST)

​Advanced Acne Wash

SPL UNCLASSIFIED SECTION

Extended - release action for lasting results

Kills bacteria that cause acne

Gentle formula

SPL UNCLASSIFIED SECTION

Manufactured for Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent No. 6979440

022004 - 2 07/2015 ©2015 Elorac, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42783-635-04

Elorac, Inc.

Advanced Acne Wash

advanced-acne-wash.jpgadvanced-acne-wash.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapPSN4
1543390benzoyl peroxide 44 MG/ML Medicated Liquid SoapSCD4
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42783-635-042020-01-31C16284748780-19d75b9d1-2976-f424-e053-dadaa90a57ceAdvanced Acne Wash (4.4% benzoyl peroxide extended release)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42783-635-04Advanced Acne Wash104 mL in 1 TUBELIQUID, EXTENDED RELEASE1044

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42783-635ADVANCED ACNE WASH (BENZOYL PEROXIDE) LIQUID, EXTENDED RELEASE [ELORAC, INC.]4Legacy NDC, 1 package rows20151009_04a73231-e495-458f-a298-1c4e8cf0662e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42783-635-04ML - Milliliter42783-635b4c72c2e-f7c4-4d33-ba79-a6e3ff13121e12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM4
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM4
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE704
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX194
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P4
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDEINACTIVE INGREDIENT9CO8OUL4TH4
LAURETH-7INACTIVE INGREDIENTZ95S6G82014
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T4
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42783-63542783-635-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
SHEA BUTTERK49155WL9YIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CANDELILLA WAXWL0328HX19IACT
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE9CO8OUL4THIACT
LAURETH-7Z95S6G8201IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 11 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
4 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate

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
2288e7cb-48aa-47e2-9550-49814fdf357804a73231-e495-458f-a298-1c4e8cf0662e2015-10-08WarningsExact identifier
spl id: 2288e7cb-48aa-47e2-9550-49814fdf3578
spl set id: 04a73231-e495-458f-a298-1c4e8cf0662e

Reported adverse events (FAERS/openFDA)#

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