SAFEWAY DANDRUFF - pyrithione zinc liquid 
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.

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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 XYLENE SULFONATE, BLUE 1 (CI 42090), RED 4 (CI 14700), YELLOW 10 (CI 47005).

QUESTIONS OR COMMENTS?

1-888-723-3929

LABEL COPY

IMAGE OF THE LABEL

SAFEWAY  DANDRUFF
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-415
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.0 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)  
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
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 RED NO. 4 (UNII: X3W0AM1JLX)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-415-14420 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/03/2012
Labeler - SAFEWAY INC. (009137209)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 12/2011
Document Id: d4adacf4-95b1-4955-9034-82588b195dcf
Set id: cd404c5c-bd53-4a3d-995d-2ddb545dc5ac
Version: 1
Effective Time: 20111216
 
SAFEWAY INC.