Ayadara Cystic Acne Spot Treatment Paste
FDA Label NDC 72841-206

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leiluna Llc for the product Ayadara Cystic Acne Spot Treatment (NDC 72841-206). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, otc - purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

DISTRIBUTED BY:
Leiluna LLC
Wilmington, DE 19807

Active Ingredient

Sulfur 3.0%

Otc - Purpose

Acne Treatment

Use

for the treatment of acne.

Warnings

For external use only.

Otc - Do Not Use

Do not use on

  • broken skin
  • large areas of the skin.

Otc - When Using

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

Stop use and ask a doctor if

  • skin irritation occurs or gets worse.

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (15 ML Jar Box)

Principal Display Panel (15 ML Jar Box)

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