FDA.reportPublic FDA data

Organic Tea Tree Treatment Gel

Manufacturer
HERRCO COSMETICS LIMITED
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:42

Label at a glance#

ProductOrganic Tea Tree Treatment Gel
Active ingredientSALICYLIC ACID
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%​

INDICATIONS & USAGE SECTION

For the treatment of acne​

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.​

OTC - PURPOSE SECTION

Acne Treatment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tea GelTea Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN3
346298salicylic acid 0.02 MG/MG Topical GelSCD3
346298salicylic acid 2 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71643-1019-12024-12-24C16284748780-1ba0f9c33-1620-a910-e053-dadaa90a0b85Organic Tea Tree Treatment Gel
71643-1019-12021-01-29C16284748780-1ba0f9c33-1620-a910-e053-dadaa90a0b85Organic Tea Tree Treatment Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71643-1019-1Organic Tea Tree Treatment Gel10 mL in 1 BOXGEL103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71643-1019ORGANIC TEA TREE TREATMENT GEL (SALICYLIC ACID 2% GEL) GEL [HERRCO COSMETICS LIMITED]3Legacy NDC, 1 package rows20241226_5900c07c-2e6f-3f2b-e053-2a91aa0a95ff.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71643-101971643-1019-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
BILBERRY9P2U39H18WIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
COCO-CAPRYLATE4828G836N6IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUGARCANE81H2R5AOH3IACT
ORANGE5EVU04N5QUIACT
ACER SACCHARUM BARK/SAPZ120VL0KACIACT
LEMON OILI9GRO824LLIACT
ROSEMARY OIL8LGU7VM393IACT
LIME OILUZH29XGA8GIACT
SALIX ALBA BARK205MXS71H7IACT
TEA TREE OILVIF565UC2GIACT
SPEARMINT OILC3M81465G5IACT
CUCUMBERYY7C30VXJTIACT
CHAMOMILEFGL3685T2XIACT
CITRUS PARADISI SEED12F08874Y7IACT
ECHINACEA PURPUREAQI7G114Y98IACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHYTATE SODIUM88496G1ERLIACT
SODIUM HYDROXIDE55X04QC32IIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GRAPEFRUIT PEEL3582N05Q44IACT
LEMON24RS0A988OIACT
ALCOHOL3K9958V90MIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML · Source PDF

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
29ba06d9-0cad-f1fb-e063-6294a90ad2a95900c07c-2e6f-3f2b-e053-2a91aa0a95ff2024-12-20Exact identifier
spl id: 29ba06d9-0cad-f1fb-e063-6294a90ad2a9
spl set id: 5900c07c-2e6f-3f2b-e053-2a91aa0a95ff

Reported adverse events (FAERS/openFDA)#

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