FDA.reportPublic FDA data

Drying Lotion

Manufacturer
Renu Laboratories, Inc.
Effective date
2023-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:21

Label at a glance#

ProductADARA Acne 911 Drying
Active ingredientSULFUR
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sulfur Colloidal (10%)

OTC - PURPOSE SECTION

Purpose

Topical Acne Treatment

INDICATIONS & USAGE SECTION

Uses

  • for the treatment of acne
  • healing and drying acne breakouts
  • helps clear acne pimples, blackheads or whiteheads and allows skin to heal
  • penetrates pores to control acne blemishes
  • helps keep skin clear of new acne pimples

WARNINGS SECTION

Warnings

For external use only

  • 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 - DO NOT USE SECTION

Do Not Use

  • on broken skin
  • on large areas of the skin
  • if pregnant or breast-feeding, ask a health professional before use.

OTC - WHEN USING SECTION

When using this product

  • apply only to areas with acne

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • excessive dryness or peeling occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Do Not Shake

  • clean skin thoroughly before applying this product
  • carefully place wand or cotton swab into sediment at bottom and apply directly to the blemish
  • 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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Camphor, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid,
Zinc Oxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABEL ART SHOWN BELOW

ACNE 911 LABELACNE 911 LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240725sulfur 10 % Topical LotionPSN1
240725sulfur 100 MG/ML Topical LotionSCD1
240725sulfur 10 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-890-012025-01-30C16284748780-12cef2736-b65a-d83d-e063-dadaa90ab31fDrying Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-890-01ADARA Acne 911 Drying14 g in 1 BOTTLE, GLASSSUSPENSION141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-890ADARA ACNE 911 DRYING (ACNE DRYING LOTION) SUSPENSION [RENU LABORATORIES, INC.]11 package rows20231003_02e3dd2c-45d8-9419-e063-6294a90a2206.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-89076348-890-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ZINC OXIDESOI2LOH54ZIACT
SALICYLIC ACIDO414PZ4LPZIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
ISOPROPYL ALCOHOLND2M416302IACT
SULFUR70FD1KFU70ACTIB
FERRIC OXIDE RED1K09F3G675IACT

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
02e3dd2c-45d9-9419-e063-6294a90a220602e3dd2c-45d8-9419-e063-6294a90a22062023-08-14WarningsExact identifier
spl id: 02e3dd2c-45d9-9419-e063-6294a90a2206
spl set id: 02e3dd2c-45d8-9419-e063-6294a90a2206

Reported adverse events (FAERS/openFDA)#

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