FDA.reportPublic FDA data

Acne Fighting Spot Gel with Aloe clear

Manufacturer
Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2023-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:37

Label at a glance#

ProductAcne Fighting Spot with Aloe clear
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne Helps prevent new acne blemishes

Dosage and administration

Cleanse the skin thoroughly before applying medication. 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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Helps prevent new acne blemishes

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove.
  • 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse the skin thoroughly before applying medication.
  • 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.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Camphor, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Sodium Benzoate

Questions or comments

OTC - QUESTIONS SECTION

1-855-353-7320

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251380salicylic acid 1 % Topical GelPSN3
251380salicylic acid 0.01 MG/MG Topical GelSCD3
251380salicylic acid 1 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70412-411-06Acne Fighting Spot with Aloe clear1 in 1 BOXGEL13
70412-411-06Acne Fighting Spot with Aloe clear6 mL in 1 BOTTLEGEL63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70412-411ACNE FIGHTING SPOT WITH ALOE CLEAR (SALICYLIC ACID) GEL [ZHEJIANG AYAN BIOTECH CO.,LTD.]3Current NDC, Legacy NDC, 2 package rows20231122_db0054b1-29b9-48fa-8a02-86683bae8134.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70412-41170412-411-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
TEA TREE OILVIF565UC2GIACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM BENZOATEOJ245FE5EUIACT
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
Acne Fighting Spot with Aloe clearSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.db0054b1-29b9-48fa-8a02-86683bae81342023-11-21WarningsExact identifier
ndc (package): 70412-411-06
ndc (product): 70412-411
ndc11 (package): 70412041106
spl id: 0aadd7d7-6eea-5012-e063-6394a90a0e4c
spl set id: db0054b1-29b9-48fa-8a02-86683bae8134

Reported adverse events (FAERS/openFDA)#

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