FDA.reportPublic FDA data

DRY IT OUT ACNE SPOT TREATMENT

Manufacturer
Pacifica Beauty LLC. | Sun Deep Inc.
Effective date
2020-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:24

Label at a glance#

ProductDRY IT OUT ACNE SPOT TREATMENT
Active ingredientSalicylic Acid
Label structure9 sections

Dosage and administration

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. sensitivity test for a ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only. Flammable: Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

  • 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 - 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • 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

Aqua, Alcohol Denat., Glycerin, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Juice1, Hydroxyethylcellulose, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract1, Spiraea Ulmaria (Meadowsweet) Extract, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Lens Esculenta (Lentil) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract1, Chamomilla Recutita (Matricaria) Flower Extract1, Camellia Sinensis (White Tea) Leaf Extract1, Arnica Montana Flower Extract1, Dipotassium Glycyrrhizate, Parfum2.

1 certified organic

2 our scent blend with natural and/or essential oils

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-322-2466

Pacifica Beauty LLC Portland, Oregon

PRINCIPAL DISPLAY PANEL - 29 ML Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACIFICA®

DRY IT
OUT
ACNE GEL
SPOT TREATMENT

maximum strength
2% salicylic acid
acne medication
+
niacinamide

100% VEGAN
CRUELTY-FREE

1 FL OZ • 29 ML

PRINCIPAL DISPLAY PANEL - 29 ML Tube Carton
PRINCIPAL DISPLAY PANEL - 29 ML Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN1
346298salicylic acid 0.02 MG/MG Topical GelSCD1
346298salicylic acid 2 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61197-102-002023-01-30C16284748780-1f386c64a-1d87-0266-e053-dadaa90a7c1aDRY IT OUT ACNE SPOT TREATMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61197-102-00DRY IT OUT ACNE SPOT TREATMENT29 mL in 1 TUBEGEL291
61197-102-00DRY IT OUT ACNE SPOT TREATMENT1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61197-102DRY IT OUT ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [PACIFICA BEAUTY LLC.]1Legacy NDC, 2 package rows20210127_d35a6483-1184-4ad2-9e8e-a4a4f8dd8ba4.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61197-10261197-102-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
Alcohol3K9958V90MIACT
GlycerinPDC6A3C0OXIACT
Hamamelis Virginiana TopUDA30A2JJYIACT
Aloe Vera LeafZY81Z83H0XIACT
Niacinamide25X51I8RD4IACT
CucumberYY7C30VXJTIACT
Sage OilU27K0H1H2OIACT
Peppermint OilAV092KU4JHIACT
Lens Culinaris FruitZYZ076G9JHIACT
Lavandula Angustifolia Subsp. Angustifolia Flowering Top9YT4B71U8PIACT
ChamomileFGL3685T2XIACT
White TeaO0M3396E09IACT
Arnica Montana FlowerOZ0E5Y15PZIACT
Glycyrrhizinate DipotassiumCA2Y0FE3FXIACT

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
cfd9e63b-80c6-4126-9975-aea2d2488e81d35a6483-1184-4ad2-9e8e-a4a4f8dd8ba42020-01-06WarningsExact identifier
spl id: cfd9e63b-80c6-4126-9975-aea2d2488e81
spl set id: d35a6483-1184-4ad2-9e8e-a4a4f8dd8ba4

Reported adverse events (FAERS/openFDA)#

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