Leiluna (as PLD) - TreeActiv Spot Treatment (72841-205) - DELIST

TreeActiv Spot Treatment by

Drug Labeling and Warnings

TreeActiv Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Leiluna LLC, HealthSpecialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TREEACTIV SPOT TREATMENT- sulfur paste 
Leiluna LLC

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Leiluna (as PLD) - TreeActiv Spot Treatment (72841-205) - DELIST

DRUG FACTS

ACTIVE INGREDIENTS

Sulfur 3.0%

Acne Treatment

USE

for the treatment of acne

WARNING

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.

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

Water, Aloe Barbadensis Leaf Juice, Bentonite, Hamamelis Virginiana (Witch Hazel) Extract, Cetyl Alcohol, Glyceryl Stearate, Tea Tree (Melaleuca Alternifolia) Leaf Oil, Dimethicone, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Mentha Piperita (Peppermint) oil, Citrus Paradisi (Grapefruit) Oil, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate

QUESTIONS?

888-201-6444 | hello@treeactiv.com

DISTRIBUTED BY:
Leiluna LLC | Wilmington, DE 19807

PRINCIPAL DISPLAY PANEL - 15 ml Jar Box

TREEACTIV

MILIA & ACNE
SPOT TREATMENT

SULFUR 3% | BENTONITE CLAY | TEA TREE OIL

0.5 fl oz (15 ml)

TREEACTIV SPOT TREATMENT 
sulfur paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72841-205
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENTONITE (UNII: A3N5ZCN45C)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
DIMETHICONE (UNII: 92RU3N3Y1O)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GRAPEFRUIT OIL (UNII: YR377U58W9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72841-205-01	1 in 1 BOX	04/05/2023	12/31/2023
1		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	04/05/2023	12/31/2023

Labeler - Leiluna LLC (080065214)

Revised: 3/2024

Document Id: 14ab5253-f2bd-8130-e063-6394a90a283b

34390-5

Set id: fa4d8724-6bc3-4453-8994-e7f964c7356a

Version: 2

Effective Time: 20240327