Label: HEAD AND SHOULDERS RENEWING CLEAN- pyrithione zinc lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 51769-139-01, 51769-139-05, 51769-139-11, 51769-139-18, view more51769-139-20, 51769-139-40, 51769-139-50, 51769-139-70 - Packager: ALL NATURAL DYNAMICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 29, 2013
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- Active ingredient
- Uses
- Warnings
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Inactive ingredients
Water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.
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INGREDIENTS AND APPEARANCE
HEAD AND SHOULDERS RENEWING CLEAN
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51769-139 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 laureth sulfate (UNII: BPV390UAP0) sodium lauryl sulfate (UNII: 368GB5141J) Coco Monoethanolamide (UNII: C80684146D) zinc carbonate (UNII: EQR32Y7H0M) glycol distearate (UNII: 13W7MDN21W) dimethicone (UNII: 92RU3N3Y1O) guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) (UNII: B16G315W7A) magnesium sulfate (UNII: DE08037SAB) sodium benzoate (UNII: OJ245FE5EU) magnesium carbonate hydroxide (UNII: YQO029V1L4) sodium chloride (UNII: 451W47IQ8X) methylchloroisothiazolinone (UNII: DEL7T5QRPN) methylisothiazolinone (UNII: 229D0E1QFA) sodium xylenesulfonate (UNII: G4LZF950UR) FD&C blue no. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51769-139-40 400 mL in 1 BOTTLE, PLASTIC 2 NDC:51769-139-50 500 mL in 1 BOTTLE, PLASTIC 3 NDC:51769-139-20 200 mL in 1 BOTTLE, PLASTIC 4 NDC:51769-139-70 700 mL in 1 BOTTLE, PLASTIC 5 NDC:51769-139-11 1000 mL in 1 BOTTLE, PLASTIC 6 NDC:51769-139-18 1180 mL in 1 BOTTLE, PLASTIC 7 NDC:51769-139-05 50 mL in 1 BOTTLE, PLASTIC 8 NDC:51769-139-01 10 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/29/2013 Labeler - ALL NATURAL DYNAMICS (962732892) Establishment Name Address ID/FEI Business Operations Procter & Gamble Manufactura, S. de R.L. de C.V. 810007526 manufacture(51769-139)