Label: 2 IN 1 DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 55910-942-15, 55910-942-35
- 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 January 16, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
-
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, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5
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SPL UNCLASSIFIED SECTION
2 IN 1 Dandruff Shampoo + Conditioner Pyrithione Zinc 1%
Green Apple
Multiple benefit formula to help:- Fight dry scalp
- Calm itch
- Relieve irritation
- Soothe and reduce redness
- Reduce oilines
- Prevent flakes
- Leave hair healthy looking
*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Green Apple 2 in 1 Dandruff Shampoo & conditioner.
DISTRIBUTED BY DOLGENCORP, LLC
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GOODLETTSVILLE, TN 37072
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INGREDIENTS AND APPEARANCE
2 IN 1 DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-942 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 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) 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-942-35 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/18/2016 2 NDC:55910-942-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 01/18/2016 Labeler - DOLGENCORP, LLC (068331990) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(55910-942)