FDA.reportPublic FDA data

Peace Out Early Stage Acne Dot

Manufacturer
Peace Out LLC.
Effective date
2024-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:55

Label at a glance#

ProductPeace Out Early Stage Acne Dot
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

For the treatment of acne

Dosage and administration

For products applied to and left on the skin: Cleanse thoroughly before applying this product Because excessive drying of the skin may occur, start with on application daily, then gradually increase to two to three times a day if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or even every other day Sensitivity Test for a New User . Apply product sparing...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only. When Using This Product

  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only one medication should be used.
  • Do not use if you are allergic to the dressing or any of its components.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For products applied to and left on the skin:

  • Cleanse thoroughly before applying this product
  • Because excessive drying of the skin may occur, start with on application daily, then gradually increase to two to three times a day if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or even every other day
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sodium Hyaluronate, Cellulose Gum, Glycerin, Trehalose, Niacinamide, Propanediol, Succinic Acid, Mandelic Acid, Caprylyl Glycol, Madecassoside, Potassium Hydroxide, Ethylhexylglycerin, Oligopeptide-76

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-268-1962 M-F 9AM TO 5PM PST

Other

OTHER SAFETY INFORMATION

  • Store between 17ºC - 30ºC

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546588salicylic acid 2 % Medicated PatchPSN3
1546588salicylic acid 0.02 MG/MG Medicated PatchSCD3
1546588salicylic acid 2 % Medicated PatchSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71494-007-01Peace Out Early Stage Acne Dot1 in 1 CARTONPATCH13
71494-007-01Peace Out Early Stage Acne Dot8 in 1 POUCHPATCH83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71494-007PEACE OUT EARLY STAGE ACNE DOT (SALICYLIC ACID) PATCH [PEACE OUT LLC.]3Current NDC, 2 package rows20240622_0632d458-d326-ade4-e063-6294a90af3ba.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
71494-00771494-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM HYDROXIDEWZH3C48M4TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
NIACINAMIDE25X51I8RD4IACT
MADECASSOSIDECQ2F5O6YIYIACT
SUCCINIC ACIDAB6MNQ6J6LIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
TREHALOSEB8WCK70T7IIACT
HYALURONATE SODIUMYSE9PPT4THIACT
MANDELIC ACIDNH496X0UJXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
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
Peace Out Early Stage Acne DotSALICYLIC ACIDPeace Out LLC.0632d458-d326-ade4-e063-6294a90af3ba2024-06-20WarningsExact identifier
ndc (package): 71494-007-01
ndc (product): 71494-007
ndc11 (package): 71494000701
spl id: 1b5d4d59-2100-0774-e063-6294a90ae018
spl set id: 0632d458-d326-ade4-e063-6294a90af3ba

Reported adverse events (FAERS/openFDA)#

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