AYADARA CYSTIC ACNE SPOT TREATMENT- sulfur paste

Ayadara Cystic Acne Spot Treatment by

Drug Labeling and Warnings

Ayadara Cystic Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Leiluna LLC, Island Kinetics, Inc. d.b.a. CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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DRUG FACTS

ACTIVE INGREDIENT

Sulfur 3.0%

PURPOSE

Acne Treatment

USE

for the treatment of acne.

WARNINGS

For external use only.

Do not use on

• broken skin
• large areas of the skin.

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.

Stop use and ask a doctor if

• skin irritation occurs or gets worse.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• 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

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?

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

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DISTRIBUTED BY:
Leiluna LLC
Wilmington, DE 19807

PRINCIPAL DISPLAY PANEL - 15 ML Jar Box

Ayadara

warrior two
CYSTIC, HORMONAL & SEVERE ACNE SPOT TREATMENT

OVERNIGHT

+TEA TREE OIL + ALOE
+BENTONITE CLAY +SPEARMINT

0.5 FL OZ (15 ML)

INGREDIENTS AND APPEARANCE

AYADARA CYSTIC ACNE SPOT TREATMENT 
sulfur paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72841-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
BENTONITE (UNII: A3N5ZCN45C)
ALCOHOL (UNII: 3K9958V90M)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
ACACIA (UNII: 5C5403N26O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
DIMETHICONE (UNII: 92RU3N3Y1O)
SPEARMINT OIL (UNII: C3M81465G5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALLANTOIN (UNII: 344S277G0Z)
GRAPEFRUIT OIL (UNII: YR377U58W9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72841-206-01	1 in 1 BOX	01/01/2025
1		15 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 72841-206-02	2 in 1 PACKAGE, COMBINATION	01/01/2025
2		1 in 1 BOX
2		15 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	01/01/2025

Labeler - Leiluna LLC (080065214)

Establishment
Name	Address	ID/FEI	Business Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories		959735002	MANUFACTURE(72841-206)