HEB DANDRUFF- pyrithione zinc shampoo 
HEB

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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DRUG FACTS

ACTIVE INGREDIENT

PYRITHIONE ZINC 1%

PURPOSE

ANTI-DANDRUFF

USES

HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

WARNINGS

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 WORSONS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO

WET HAIR, MASSAGE ONTO SCALP, RINSE, REPEAT IF DESIRED

FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED  BY A DOCTOR

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE DEA, ZINC CARBONATE, GLYCOL DISTEARATE, FRAGRANCE, DIMETHICONE, CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MENTHOL, PEG-7M, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, SEA SALT, FUCUS  VESICULOSUS EXTRACT, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE,  SODIUM XYLENE SULFONATE, BLUE 1, YELLOW 5

LABEL COPY

image of the label

HEB  DANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-424
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
ZINC CARBONATE (UNII: EQR32Y7H0M)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
SEA SALT (UNII: 87GE52P74G)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-424-14420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/23/2011
Labeler - HEB (007924756)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 12/2011
Document Id: 530448e2-f128-4609-a3e7-01d4b8fe0edf
Set id: 9e5835e9-28d1-44ef-828d-af5a6c04ea78
Version: 1
Effective Time: 20111223
 
HEB