Label: DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 55910-353-15
- Packager: DOLGENCORP, LLC
- 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 February 13, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
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Inactive ingredients
water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodim benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, citric acid, blue 1, red 33
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SPL UNCLASSIFIED SECTION
Equaline Smooth Spice 2 in 1 Dandruff Shampoo & Conditioner
*This product is not manufactured or distributed by the Procter & Gamble Company, distributor of Head & Shoulders Dandruff Shampoo & Conditioner Old Spice
Multiple benefit formula to help: fight dry scalp, calm itch, relieve irritation, soothe and reduce redness, reduce oiliness, prevent flakes, leave hair healthy looking
Distribured by Dolgencorp, LLC
100 Mision Ridge
Goodlettsville, TN 37072
253.001/253AB
- principal display panel
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INGREDIENTS AND APPEARANCE
DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-353 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 (800 CST) (UNII: 363Z2T48P7) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM BENZOATE (UNII: OJ245FE5EU) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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:55910-353-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/21/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/21/2015 Labeler - DOLGENCORP, LLC (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-353) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-353)