FDA.reportPublic FDA data

Acne Dots

Manufacturer
Hangzhou Caring Cleaning Commodity Co., Ltd
Effective date
2024-05-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:19

Label at a glance#

ProductAcne Dots
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

Soothe and help diminish the redness and irritation of blemished skin & absorbs excess oil for faster healing.

Dosage and administration

Cleanse and dry face, removing any make up. Apply one healing dot, sticky side down, over your blemish. Leave the healing dot over blemish for at least 6 hours or overnight. Repeat as necessary with a new healing dot.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid, 0.5%. Purpose: Acne treatment

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

Soothe and help diminish the redness and irritation of blemished skin & absorbs excess oil for faster healing.

Warnings

WARNINGS SECTION

For external use only.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse and dry face, removing any make up.

Apply one healing dot, sticky side down, over your blemish.

Leave the healing dot over blemish for at least 6 hours or overnight.

Repeat as necessary with a new healing dot.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11223344

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1994404salicylic acid 0.5 % Medicated PatchPSN1
1994404salicylic acid 0.005 MG/MG Medicated PatchSCD1
1994404salicylic acid 0.5 % Medicated PatchSY1

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
78936-403-01Acne Dots17 mg in 1 PATCHPATCH171
78936-403-02Acne Dots20 in 1 BOXPATCH201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78936-403ACNE DOTS (SALICYLIC ACID) PATCH [HANGZHOU CARING CLEANING COMMODITY CO., LTD]12 package rows20240511_18181e3c-3e3b-2624-e063-6394a90aaf0d.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78936-40378936-403-01, 78936-403-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF 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
18181e3c-3e3a-2624-e063-6394a90aaf0d18181e3c-3e3b-2624-e063-6394a90aaf0d2024-05-10WarningsExact identifier
spl id: 18181e3c-3e3a-2624-e063-6394a90aaf0d
spl set id: 18181e3c-3e3b-2624-e063-6394a90aaf0d

Reported adverse events (FAERS/openFDA)#

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