FDA.reportPublic FDA data

StrataClear

Manufacturer
Stratpharma AG
Effective date
2022-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:01:15

Label at a glance#

ProductStrataClear
Active ingredientSALICYLIC ACID
Label structure12 sections

Storage and handling

Other information store at 19-24 º C (66-75 º F)

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Salicylic Acid  2%

OTC - PURPOSE SECTION

Purpose

Acne Treatment

INDICATIONS & USAGE SECTION

Uses

  • treats acne
  • helps prevent new acne
  • dries up acne

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on broken skin
  • if pregnant or lactating

OTC - WHEN USING SECTION

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • do not use in or near eyes
  • note that using other topical acne drugs at the same time or right after use of this product may increase dryness or skin irritation.

OTC - STOP USE SECTION

Stop use and ask a doctor if

too much skin irritation or sensitivity develops or increases.

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

  • gently massage cleanser onto skin and remove with lukewarm water.
  • use once daily, alternating use with another, non-drug cleanser
  • if bothersome dryness or peeling occurs, reduce application to every other day.  

STORAGE AND HANDLING SECTION

Other information

store at 19-24 ºC (66-75 ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients:  Water (Aqua), Sorbitol, Ammonium Lauryl Sulfate, Cetyl Alcohol, Stearyl Alcohol, PPG-12/SMDI Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73661-45873661-458-20

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TEA TREE OILVIF565UC2GIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
0bc7f6c8-8141-9292-e063-6294a90a2bfb752c31e1-d21c-45a2-8d91-141d842d0c412023-12-05WarningsExact identifier
spl set id: 752c31e1-d21c-45a2-8d91-141d842d0c41

Reported adverse events (FAERS/openFDA)#

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