FDA.reportPublic FDA data

Tiége Hanley Daily Moisturizing Acne Cream

Manufacturer
TIEGE HANLEY,Inc. | BMC 1092, Inc. dba Solo Laboratories, Inc
Effective date
2023-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:32

Label at a glance#

ProductTiege Hanley Daily Moisturizing Acne
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

For the management of acne

Dosage and administration

Clean face thoroughly with Tiege Hanley WASH before applying this product Dispense approximately 3 pumps–enough to cover the entire affected area with a thin layer, including the face and neck For best results, use before bedtime For severe acne, add morning application after WASH, only if followed by AM moisturizer with SPF 20 Because excessive drying of the skin may occur, start with one application daily, then ...

Storage and handling

When not using, keep at room temperature with the cap closed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.6%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the management of acne

Warnings

WARNINGS SECTION

  • For External Use Only

When using this product

OTC - WHEN USING SECTION

  • do not use this product more than twice per day
  • discontinue use if skin irritation occurs
  • avoid contact with eyes
  • if going outside, apply sunscreen after using this product
  • skin irritation and dryness are more likely to occur if you use more than one acne medication at the same time
  • if irritations occur only use one topical acne medication at a time
  • avoid aggressive soaps if irritations are experienced

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to salicylic acid

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean face thoroughly with Tiege Hanley WASH before applying this product
  • Dispense approximately 3 pumps–enough to cover the entire affected area with a thin layer, including the face and neck
  • For best results, use before bedtime
  • For severe acne, add morning application after WASH, only if followed by AM moisturizer with SPF 20
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once per day or every other day

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Cyclopentasiloxane, Cocamidopropyl Dimethylamine, Ethyl Palmate, Behenyl Alcohol, Zea Mays (Corn) Starch, Beheneth-5, Polyglyceryl-3 Stearate, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ceteareth-25, Medicago Sativa (Alfalfa) Extract, Plantago Major Leaf Extract, Calendula Officinalis Flower Extract, Aleurites Moluccanus Seed Oil, Xanthan Gum, Sodium Hyaluronate

Other Information

STORAGE AND HANDLING SECTION

  • When not using, keep at room temperature with the cap closed

SPL UNCLASSIFIED SECTION

  • Distributed by Tiege Hanley, Inc.
    Chicago, IL 60612

PRINCIPAL DISPLAY PANEL - 24 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TIÉGE
HANLEY

Uncomplicated
Skin Care for Men®

ACNE

Daily Moisturizing
Acne Cream

Net Wt 0.85 oz (24 g)

Principal Display Panel - 24 g Bottle Label
Principal Display Panel - 24 g Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2632542salicylic acid 1.6 % Topical CreamPSN1
2632542salicylic acid 16 MG/ML Topical CreamSCD1
2632542salicylic acid 1.6 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71714-002-242025-01-30C16284748780-11030e365-0280-111a-e063-dadaa90a10e2Tiége Hanley Daily Moisturizing Acne Cream
71714-002-242024-09-20C16284748780-11030e365-0280-111a-e063-dadaa90a10e2Tiége Hanley Daily Moisturizing Acne Cream
71714-002-242024-07-30C16284748780-11030e365-0280-111a-e063-dadaa90a10e2Tiége Hanley Daily Moisturizing Acne Cream
71714-002-242024-01-30C16284748780-11030e365-0280-111a-e063-dadaa90a10e2Tiége Hanley Daily Moisturizing Acne Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71714-002-24Tiege Hanley Daily Moisturizing Acne24 g in 1 BOTTLE, PUMPCREAM241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71714-002TIEGE HANLEY DAILY MOISTURIZING ACNE (SALICYLIC ACID) CREAM [TIEGE HANLEY,INC.]11 package rows20230322_5d299c57-4e36-4322-8763-55ff78920dae.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71714-00271714-002-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
STARCH, CORNO8232NY3SJIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-3 STEARATE8FDA8C98S3IACT
BEHENETH-5L4A971L76EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CETEARETH-258FA93U5T67IACT
ETHYL PALMATEPY7890FR5MIACT
DOCOSANOL9G1OE216XYIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALFALFA TOPSQI2NBY9KRIACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
KUKUI NUT OILTP11QR7B8RIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT

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
9d9c37ae-e792-48f1-9f90-76f1d35f62c95d299c57-4e36-4322-8763-55ff78920dae2023-03-20WarningsExact identifier
spl id: 9d9c37ae-e792-48f1-9f90-76f1d35f62c9
spl set id: 5d299c57-4e36-4322-8763-55ff78920dae

Reported adverse events (FAERS/openFDA)#

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