HEB DANDRUFF- pyrithione zinc shampoo

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)
Available from:
HEB
INN (International Name):
PYRITHIONE ZINC
Composition:
PYRITHIONE ZINC 1 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
ANTI-DANDRUFF HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF
Authorization status:
OTC monograph final
Authorization number:
37808-424-14

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.

----------

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:378 0 8 -424

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5)

PYRITHIONE ZINC

1 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)

ZINC CARBO NATE (UNII: EQR32Y7H0 M)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

PO LYQ UATERNIUM-10 ( 4 0 0 CPS AT 2 %) (UNII: HB140 1PQFS)

MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE0 8 0 37SAB)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

MENTHO L (UNII: L7T10 EIP3A)

PO LYETHYLENE GLYCO L 7 0 0 0 (UNII: Q0 JET6 5GEL)

MAGNESIUM CARBO NATE HYDRO XIDE (UNII: YQO0 29 V1L4)

AMMO NIUM LAURETH-3 SULFATE (UNII: 8 9 6 SJ235FN)

SEA SALT (UNII: 8 7GE52P74G)

FUCUS VESICULO SUS (UNII: 535G2ABX9 M)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

SO DIUM XYLENESULFO NATE (UNII: G4LZF9 50 UR)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:378 0 8 -424-14

420 mL in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

12/23/20 11

Labeler -

HEB (007924756)

Registrant -

APOLLO HEALT H AND BEAUT Y CARE (201901209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

APOLLO HEALTH AND BEAUTY CARE

20 19 0 120 9

ma nufa c ture

Revised: 12/2011

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