CONTROL ANTI-DANDRUFF- pyrithione zinc shampoo
AG Hair Ltd.

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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Control Anti-Dandruff Shampoo

ACTIVE INGREDIENT:

ZINC PYRIDINETHIONE (PYRITHIONE) 2%

PURPOSE:

Anti-Dandruff

USES:

HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF.

WARNING:

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT:

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF:

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS:

USE TWICE A WEEK, OR AS DIRECTED BY A PHYSICIAN FOR CHRONIC CONDITIONS.
MASSAGE INTO SCALP FOR 3-5 MINUTES. RINSE THOROUGHLY.

INACTIVE INGREDIENTS

WATER (AQUA, EAU), AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-4 RAPESEEDAMIDE, ALOE BARBADENSIS EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM HYDROXIDE, PANTHENOL, HYDROLYZED KERATIN, SODIUM PCA, TOCOPHERYL ACETATE, SODIUM HYDROXYMETHYLGLYCINATE, CITRIC ACID, FRAGRANCE (PARFUM), ENTHOL, TETRASODIUM GLUTAMATE DIACETATE, PROPANEDIOL.

QUESTIONS (OR COMMENTS)?

1-866-924-4247

PRODUCT LABELING

Anti-Dandruff Shampoo2

CONTROL ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46324-2421
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)
ALOE (UNII: V5VD430YW9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MENTHOL (UNII: L7T10EIP3A)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
PROPANEDIOL (UNII: 5965N8W85T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46324-2421-8	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2011	06/30/2016
2	NDC:46324-2421-1	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2011	11/30/2015
3	NDC:46324-2421-2	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2011	10/14/2024
4	NDC:46324-2421-3	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2011	10/28/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	10/28/2011	10/31/2024

Labeler - AG Hair Ltd. (203691886)

Revised: 6/2023

Document Id: fe2f6deb-f097-e0c8-e053-6394a90a692a

Set id: 9c719fb7-57cc-4871-b11d-f449e18697c9

Version: 20

Effective Time: 20230615

AG Hair Ltd.