HEAD AND SHOULDERS TEA TREE OIL DAILY- pyrithione zinc lotion/shampoo The Procter & Gamble Manufacturing Company 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. ------
Head and Shoulders ® Tea Tree Oil Shampoo
Men Old Spice ® Pure Sport 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 worsens or does not improve after regular use of this product as directed.
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions for best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo. shake before use. wet hair, massage onto scalp, rinse, repeat if desired.
Inactive ingredients Water, sodium laureth sulfate, cocamide MEA, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, fragrance, sodium chloride, dimethicone, menthol, guar hydroxypropyltrimonium chloride, sodium benzoate, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, polyquaternium-76, mentha piperita (peppermint) oil, mentha arvensis leaf oil, melaleuca alternifolia (tea tree) leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.
Questions (or comments)? 1-800-723-9569 Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202
PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label head & shoulders ® pyrithione zinc dandruff shampoo TEA TREE OIL DAILYI SHAMPOO HYDRATES AND COOLS FOR SCALP RELIEF INFUSED with tea tree oil FLAKE FREE UP TO 100% GUARANTEED
13.5 FL OZ (400 mL) HEAD AND SHOULDERS TEA TREE OIL DAILY pyrithione zinc lotion/shampoo
Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 9 423-416
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 10 0 mL
Inactive Ingredients Ingredient Name Strength CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX) STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y) CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D) MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) TEA TREE O IL (UNII: VIF56 5UC2G) FD&C YELLO W NO . 5 (UNII: I753WB2F1M) GLYCO L DISTEARATE (UNII: 13W7MDN21W) WATER (UNII: 0 59 QF0 KO0 R) SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J) SO DIUM LAURETH-3 SULFATE (UNII: BPV39 0 UAP0 ) ZINC CARBO NATE (UNII: EQR32Y7H0 M) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) SO DIUM XYLENESULFO NATE (UNII: G4LZF9 50 UR) DIMETHICO NE (UNII: 9 2RU3N3Y1O) 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) METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN) METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA) FD&C BLUE NO . 1 (UNII: H3R47K3TBD) CETYL ALCO HO L (UNII: 9 36 JST6 JCN) PEPPERMINT O IL (UNII: AV0 9 2KU4JH) MENTHA ARVENSIS LEAF O IL (UNII: 1AEY1M553N)
Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:6 9 423-416 - 40 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n 1 11/21/20 19 40 Pro duct NDC:6 9 423-416 - 9 50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n 2 0 1/15/20 21 9 5 Pro duct NDC:6 9 423-416 - 3 2 in 1 CELLO PACK 0 1/15/20 21 0 1 9 50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n 3 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 11/21/20 19 Labeler - T he Procter & Gamble Manufacturing Company (004238200)
Revised: 1/2021 The Procter & Gamble Manufacturing Company