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HEB DANDRUFF by HEB

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 1mL in 100mL
Labeler: HEB
NDC Code: 37808-424

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.

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

HEB  DANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-424
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
SODIUM LAURYL SULFATE 
COCO MONOETHANOLAMIDE 
ZINC CARBONATE 
GLYCOL DISTEARATE 
DIMETHICONE 
CETYL ALCOHOL 
POLYQUATERNIUM-10 (400 CPS AT 2%) 
MAGNESIUM SULFATE, UNSPECIFIED 
SODIUM BENZOATE 
MENTHOL 
POLYETHYLENE GLYCOL 7000 
MAGNESIUM CARBONATE HYDROXIDE 
AMMONIUM LAURETH-3 SULFATE 
SEA SALT 
FUCUS VESICULOSUS 
BENZYL ALCOHOL 
SODIUM CHLORIDE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM XYLENESULFONATE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
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/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 12/2011
 
HEB

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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