TREEACTIV CYSTIC ACNE SPOT TREATMENT- sulfur paste

TreeActiv Cystic Acne Spot Treatment by

Drug Labeling and Warnings

TreeActiv 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]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

Sulfur 3.0%

PURPOSE

Acne Treatment

USE

for the treatment of acne.

WARNINGS

For external use only. 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. Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Apply to affected areas only. Do not use on broken skin or apply to large areas of the body.

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 Extract1, 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 Powder1

1 Denotes Organic Ingredient

QUESTIONS?

888-201-6444 | CustomerCare@treeactiv.com

PRINCIPAL DISPLAY PANEL - 15 ML Jar Box

TreeActiv

Cystic Acne
Spot Treatment

ACNE TREATMENT
SPOT PASTE

0.5 FL OZ (15ML)

INGREDIENTS AND APPEARANCE

TREEACTIV CYSTIC ACNE SPOT TREATMENT 
sulfur paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72841-201
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 (UNII: I9GRO824LL)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
DIMETHICONE (UNII: 92RU3N3Y1O)
MENTHA SPICATA 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: 72841-201-01	1 in 1 BOX	05/07/2020
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 FINAL	part333D	05/07/2020

Labeler - Leiluna LLC (080065214)

Establishment
Name	Address	ID/FEI	Business Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories		959735002	MANUFACTURE(72841-201)