CT ORGANICS 2% ZINC PYRITHIONE WASH- zinc pyrithione liquid
CT Organics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CT ORGANICS 2% Zinc Pyrithione Wash

DRUG FACTS

Active Ingredient

Zinc Pyrithione 2%

Purpose

Dandruff
Seborrheic dermatitis

Uses

Controls, reduces and helps stop the symptoms of dandruff and seborrheic dermatitis.

Warning

For external use only.

When using this product do not use it in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Shake before use. Dispense out a generous amount and apply to your skin or scalp in massaging motions. Leave on for 30-60 seconds and rinse off thoroughly with water.

Other information

Store at room temperature.

Inactive ingredients

distilled water, extra virgin coconut oil*, cold pressed castor oil*, extra virgin olive oil*, potassium hydroxide, brown sugar*, non-GMO xanthan gum, citric acid, cetyl alcohol, non-GMO sunflower lecithin*, cetearyl alcohol, Moroccan rosemary essential oil, Australian tea tree oil*, Indian basil essential oil, aloe vera leaf powder*, phenoxyethanol, Chinese spearmint essential oil*, caprylyl glycol, sorbic acid

*certified organic ingredients

no sulfates . no parabens . no fragrance

Manufactured by
CT Organics LLC
27128 Paseo Espada B622
San Juan Capistrano, Ca 92675

For questions, contact us
www.ctorganics.com

Packaging

CT ORGANICS 2% ZINC PYRITHIONE WASH
zinc pyrithione liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70580-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
LIGHT BROWN SUGAR (UNII: 8DUZ1N7T79)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETYL ALCOHOL (UNII: 936JST6JCN)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ROSEMARY OIL (UNII: 8LGU7VM393)
TEA TREE OIL (UNII: VIF565UC2G)
BASIL OIL (UNII: Z129UMU8LE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SPEARMINT OIL (UNII: C3M81465G5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70580-102-85	251.375 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021	10/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	01/01/2021	10/01/2021

Labeler - CT Organics LLC (066143076)

Name	Address	ID/FEI	Business Operations
Establishment
CT Organics LLC		066143076	manufacture(70580-102)

Revised: 10/2021

Document Id: ffa8a4ca-a8c3-4d70-947f-755bda121f42

Set id: 468bb837-1fae-496c-b03e-68b3ab137ee0

Version: 3

Effective Time: 20211001

CT Organics LLC