Label: DRY SCALP DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 42507-281-15
- Packager: Hy-Vee, Inc
- 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 June 3, 2022
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claims
Dandruff Care for Great Looking Hair
This product helps relieve scalp dyrness, itch, irration and helps prevent flakes.
Dry Scalp Care and Shiny Clean Hair
- with moisturizers, it soothes the scalp while cleaning and conditioning the hair
- pH balanced for everyday use-even for permed or color-treated hair
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active ingredient
Pyrithione zinc 1%
Warning
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 time 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, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DRY SCALP DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-281 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10 mg 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) SODIUM CHLORIDE (UNII: 451W47IQ8X) ZINC CARBONATE (UNII: EQR32Y7H0M) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM BENZOATE (UNII: OJ245FE5EU) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALMOND OIL (UNII: 66YXD4DKO9) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-281-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/19/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/19/2002 Labeler - Hy-Vee, Inc (006925671) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(42507-281) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(42507-281)
