HEB DANDRUFF- pyrithione zinc shampoo

HEB by

Drug Labeling and Warnings

HEB by is a Otc medication manufactured, distributed, or labeled by HEB, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HEB  DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-424
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-424-14	420 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/23/2011

Labeler - HEB (007924756)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture