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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71493-001-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6b4a-111a-e063-dadaa90a10e2 | Utiliderm Acne Control Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71493-001-25 | Utiliderm Acne Control | 25 mL in 1 TUBE | GEL | 25 | 1 | |
| 71493-001-25 | Utiliderm Acne Control | 1 in 1 CARTON | GEL | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Utiliderm Acne Control
- Sulfur,Resorcinol
- BERGAMOT OIL
- MELALEUCA ALTERNIFOLIA LEAF
- NIGELLA SATIVA SEED OIL
- OLIVE OIL
- POLYSORBATE 80
- SORBITAN
- CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)
- BENZALKONIUM CHLORIDE
- ORIGANUM VULGARE SUBSP. HIRTUM WHOLE
- CARBOXYPOLYMETHYLENE
- SULFUR
- RESORCINOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71493-001 | 71493-001-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 682e804d-d5bd-c6b4-e053-2a91aa0a25f2 | 682e804d-d5bc-c6b4-e053-2a91aa0a25f2 | 2018-03-24 | Warnings | 682e804d-d5bd-c6b4-e053-2a91aa0a25f2 682e804d-d5bc-c6b4-e053-2a91aa0a25f2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
