FDA.reportPublic FDA data

Ayadara Cystic Acne Spot Treatment

Manufacturer
Leiluna LLC | Island Kinetics, Inc. d.b.a. CoValence Laboratories
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:02

Label at a glance#

ProductAyadara Cystic Acne Spot Treatment
Active ingredientSULFUR
Label structure10 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sulfur 3.0%

OTC - PURPOSE SECTION

Acne Treatment

USE

INDICATIONS & USAGE SECTION

for the treatment of acne.

WARNINGS

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on

  • broken skin
  • large areas of the skin.

OTC - WHEN USING SECTION

When using this product

  • apply only to areas with acne
  • 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 - STOP USE SECTION

Stop use and ask a doctor if

  • skin irritation occurs or gets worse.

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua (Water), Hamamelis Virginiana (Witch Hazel) Water, Bentonite, Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Acacia Senegal Gum, Caprylyl Glycol, Mentha Piperita (Peppermint) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Alcohol Denat., Mentha Piperita (Peppermint) Leaf Extract, Sodium Gluconate, Bisabolol (L-alpha), Dimethicone, Mentha Viridis (Spearmint) Leaf Oil, Citric Acid, Eucalyptus Globulus Leaf Oil, Allantoin, Citrus Paradisi (Pink Grapefruit) Peel Oil, Aloe Barbadensis Leaf Juice Powder

Questions?

OTC - QUESTIONS SECTION

(888) 201-6444 | hello@ayadara.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
Leiluna LLC
Wilmington, DE 19807

PRINCIPAL DISPLAY PANEL - 15 ML Jar Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ayadara

warrior two
CYSTIC, HORMONAL & SEVERE ACNE SPOT TREATMENT

OVERNIGHT

+TEA TREE OIL + ALOE
+BENTONITE CLAY +SPEARMINT

0.5 FL OZ (15 ML)

PRINCIPAL DISPLAY PANEL - 15 ML Jar Box
PRINCIPAL DISPLAY PANEL - 15 ML Jar Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2636729sulfur 3 % PastePSN1
2636729sulfur 0.03 MG/MG PasteSCD1
2636729sulfur 3 % PasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72841-206-01Ayadara Cystic Acne Spot Treatment1 in 1 BOXPASTE11
72841-206-01Ayadara Cystic Acne Spot Treatment15 mL in 1 JARPASTE151
72841-206-02Ayadara Cystic Acne Spot Treatment1 in 1 BOXPASTE11
72841-206-02Ayadara Cystic Acne Spot Treatment2 in 1 PACKAGE, COMBINATIONPASTE21

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72841-20672841-206-01, 72841-206-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
BENTONITEA3N5ZCN45CIACT
ALCOHOL3K9958V90MIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
ACACIA5C5403N26OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PEPPERMINT OILAV092KU4JHIACT
TEA TREE OILVIF565UC2GIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
LEVOMENOL24WE03BX2TIACT
SODIUM GLUCONATER6Q3791S76IACT
DIMETHICONE92RU3N3Y1OIACT
SPEARMINT OILC3M81465G5IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS OIL2R04ONI662IACT
ALLANTOIN344S277G0ZIACT
GRAPEFRUIT OILYR377U58W9IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
Ayadara Cystic Acne Spot TreatmentSULFURLeiluna LLC3cc17e7a-34d4-4789-a387-40e4d781091b2025-11-25WarningsExact identifier
ndc (package): 72841-206-01
ndc (package): 72841-206-02
ndc (product): 72841-206
ndc11 (package): 72841020601
ndc11 (package): 72841020602
spl id: 887f1c86-d2d9-4885-a87c-754104fb9b0d
spl set id: 3cc17e7a-34d4-4789-a387-40e4d781091b

Reported adverse events (FAERS/openFDA)#

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