Label: HEAD AND SHOULDERS SMOOTH AND SILKY- pyrithione zinc lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 51769-901-01, 51769-901-05, 51769-901-11, 51769-901-18, view more51769-901-20, 51769-901-40, 51769-901-70 - Packager: ALL NATURAL DYNAMICS
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated December 12, 2013
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- Official Label (Printer Friendly)
- WARNINGS AND PRECAUTIONS
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- When using this product
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
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Inactive ingredients
Water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, fragrance, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, pyrithione zinc, blue 1, red 33.
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS SMOOTH AND SILKY
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51769-901 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sodium lauryl sulfate (UNII: 368GB5141J) sodium laureth sulfate (UNII: BPV390UAP0) glycol distearate (UNII: 13W7MDN21W) zinc carbonate (UNII: EQR32Y7H0M) sodium chloride (UNII: 451W47IQ8X) dimethicone (UNII: 92RU3N3Y1O) COCO MONOETHANOLAMIDE (UNII: C80684146D) sodium benzoate (UNII: OJ245FE5EU) magnesium carbonate hydroxide (UNII: YQO029V1L4) methylchloroisothiazolinone (UNII: DEL7T5QRPN) methylisothiazolinone (UNII: 229D0E1QFA) POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) Cetyl Alcohol (UNII: 936JST6JCN) Magnesium Sulfate (UNII: DE08037SAB) ALOE VERA LEAF (UNII: ZY81Z83H0X) Benzyl Alcohol (UNII: LKG8494WBH) Sodium Xylenesulfonate (UNII: G4LZF950UR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51769-901-40 400 mL in 1 BOTTLE, PLASTIC 2 NDC:51769-901-70 700 mL in 1 BOTTLE, PLASTIC 3 NDC:51769-901-11 1000 mL in 1 BOTTLE, PLASTIC 4 NDC:51769-901-18 1180 mL in 1 BOTTLE, PLASTIC 5 NDC:51769-901-20 200 mL in 1 BOTTLE, PLASTIC 6 NDC:51769-901-05 50 mL in 1 BOTTLE, PLASTIC 7 NDC:51769-901-01 10 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/24/2013 Labeler - ALL NATURAL DYNAMICS (962732892) Establishment Name Address ID/FEI Business Operations Procter & Gamble Manufactura, S. de R.L. de C.V. 810007526 manufacture(51769-901)