2 IN 1 DANDRUFF- pyrithione zinc shampoo Wakefern Food Corp 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. ---------- Dandruff Shampoo 612 Active ingredient Pyrithione zinc 1% Purpose Anti-dandruff Use helps prevent recurrence of flaking and itching associated with dandruff Warnings For external use only When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use as directed Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions shake well for maximum dandruff control, use every tme 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 lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5 Multiple benefit formula to help: fight dry scalp Calm itch Relieve irritation Soothe and reduce redness Reduce oiliness Prevent flakes Leave hair healthy looking *This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders green apple 2 in 1 Dandruff Shampoo & conditioner. Distributed By: Wakefern Food Corp. 5000 Riverside Dr Keasbey, NJ 08832 Contact us: www.shoprite.com 612.001/612AC Principal display panel Compare to Head & Shoulders* Shop Rite 2 in 1 Dandruff Shampoo plus Conditioner Green Apple Battles dandruff wth a refreshing & clean scent pyrithione zinc dandruff shampoo & conditioner 14.2 FL OZ (420 mL) 2 IN 1 DANDRUFF pyrithione zinc shampoo Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:4119 0 -9 41 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5) PYRITHIONE ZINC 1 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 0 59 QF0 KO0 R) SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J) SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 ) GLYCO L DISTEARATE (UNII: 13W7MDN21W) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) ZINC CARBO NATE (UNII: EQR32Y7H0 M) SO DIUM XYLENESULFO NATE (UNII: G4LZF9 50 UR) AMO DIMETHICO NE (8 0 0 CST) (UNII: 36 3Z2T48 P7) CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX) SO DIUM BENZO ATE (UNII: OJ245FE5EU) GUAR HYDRO XYPRO PYLTRIMO NIUM CHLO RIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16 G315W7A) MAGNESIUM CARBO NATE HYDRO XIDE (UNII: YQO0 29 V1L4) CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN) METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA) FD&C BLUE NO . 1 (UNII: H3R47K3TBD) FD&C YELLO W NO . 5 (UNII: I753WB2F1M) Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:4119 0 -9 41- 420 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n 1 0 7/16 /20 14 15 Pro duct 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 part358 H 0 7/16 /20 14 Labeler - Wakefern Food Corp (069722418) Registrant - Vi-Jon (790752542) Establishment Name Addre ss ID/FEI Busine ss Ope rations Vi-Jo n 79 0 752542 manufacture(4119 0 -9 41) Revised: 5/2020 Wakefern Food Corp.