Utiliderm Acne Control Gel

Manufacturer
Sante Naturelle (A.G.) Ltee | Delta Pharma Inc | Delta Pharma Inc.
Effective date
2018-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:06

Label at a glance#

ProductUtiliderm Acne Control
Active ingredientSULFUR, RESORCINOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Sulfur 4%

Resorcinol 2%

OTC - PURPOSE SECTION

Purpose

acne medication

acne medication

INDICATIONS & USAGE SECTION

Use

for the treatment of acne

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on

■ broken skin ■ large areas of the skin

OTC - WHEN USING SECTION

When using this product

■ apply only to areas with acne ■ rinse eyes right

away with water if it gets in eyes ■ 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs

or gets worse.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get

medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

■ clean the skin thoroughly before applying this product

■ cover the entire affected area with a thin layer one to

three times daily ■ because excessive drying of the skin

may occur, start with one application daily, then gradually

increase to two or three times daily if needed or as directed

by a doctor ■ if bothersome dryness or peeling occurs,

reduce application to once a day or every other day.

INFORMATION FOR PATIENTS SECTION

Other information

■ keep tightly closed ■ keep away from heat

■ Report serious adverse reaction to:

c/o Report Reaction, LLC, P.O. Box 22,

Plainsboro, New Jersey 08536-0222

INACTIVE INGREDIENT SECTION

Inactive ingredients

Benzalkonium chloride, bergamot essential oil,

carbomer U-10, chitosan, Melaleuca alternifolia leaf

essential oil, Nigella sativa seed oil, olive oil, Origanum

vulgare whole plant essential oil, polysorbate 80,

sorbitan.

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free 1-800-781-7723.

Weekdays from 9 AM - 4 PM, Eastern time.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Capture.jpgCapture.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2003190resorcinol 2 % / sulfur 4 % Topical GelPSN1
2003190resorcinol 0.02 MG/MG / sulfur 0.04 MG/MG Topical GelSCD1
2003190resorcinol 2 % / sulfur 4 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71493-001-252024-01-30C16284748780-11030e365-6b4a-111a-e063-dadaa90a10e2Utiliderm Acne Control Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71493-001-25Utiliderm Acne Control25 mL in 1 TUBEGEL251
71493-001-25Utiliderm Acne Control1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71493-001UTILIDERM ACNE CONTROL (SULFUR,RESORCINOL) GEL [SANTE NATURELLE (A.G.) LTEE]1Legacy NDC, 2 package rows20180402_682e804d-d5bc-c6b4-e053-2a91aa0a25f2.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71493-00171493-001-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

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
682e804d-d5bd-c6b4-e053-2a91aa0a25f2682e804d-d5bc-c6b4-e053-2a91aa0a25f22018-03-24WarningsExact identifier
spl id: 682e804d-d5bd-c6b4-e053-2a91aa0a25f2
spl set id: 682e804d-d5bc-c6b4-e053-2a91aa0a25f2

Reported adverse events (FAERS/openFDA)#

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