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.

----------

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:

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:46324-2421
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46324-2421-8237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201106/30/2016
2NDC:46324-2421-11000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201111/30/2015
3NDC:46324-2421-2355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201110/14/2024
4NDC:46324-2421-359 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/201110/28/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/28/201110/31/2024
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.