SAFEWAY DANDRUFF DRY SCALP- 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:
SAFEWAY INC.
INN (International Name):
PYRITHIONE ZINC
Composition:
PYRITHIONE ZINC 1.0 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
TO HELP PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF.
Authorization status:
OTC monograph final
Authorization number:
21130-416-14

SAFEWAY DANDRUFF DRY SCALP- pyrithione zinc shampoo

SAFEWAY INC.

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

ANTIDANDRUFF

USES

TO HELP 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 WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT

AS DIRECTED.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON

CONTROL CENTER IMMEDIATELY.

DIRECTIONS

FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO. WET HAIR,

MASSAGE ONTO SCALP AND RINSE. REPEAT IF DESIRED.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE

MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, FRAGRANCE (PARFUM),

CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE,

MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, BENZYL

ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE,

METHYLISOTHIAZOLINONE, SODIUM XYLENESULFONATE.

QUESTIONS OR COMMENTS?

1-888-723-3929

LABEL COPY

SAFEWAY DANDRUFF DRY SCALP

pyrithione zinc shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21130 -416

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

1.0 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 (UNII: DE0 8 0 37SAB)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

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

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

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)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:21130 -416 -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

0 5/28 /20 12

Labeler -

SAFEWAY INC. (009137209)

Registrant -

APOLLO HEALT H AND BEAUT Y CARE (201901209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SAFEWAY INC.

APOLLO HEALTH AND BEAUTY CARE

20 19 0 120 9

ma nufa c ture

Revised: 5/2012

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