Label: HEAD AND SHOULDERS MENTHOL FRESH- pyrithione zinc lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 51769-134-40, 51769-134-70 - 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 24, 2013
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- 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 MENTHOL FRESH
pyrithione zinc lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51769-134 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) sodium xylenesulfonate (UNII: G4LZF950UR) 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:51769-134-40 400 mL in 1 BOTTLE, PLASTIC 2 NDC:51769-134-70 700 mL in 1 BOTTLE, PLASTIC 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. 812807550 manufacture(51769-134)