Label: DANDRUFF- selenium sulfide shampoo
- NDC Code(s): 72288-816-15
- Packager: AMAZON.COM SERVICES 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 12, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
- Ask a doctor before use if
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
-
Inactive ingredients
water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, amodimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydrogen peroxide, hydroxypropyl methylcellulose, methylchlorisothiazolinone, methylisothiazolinone, red 4
- SPL UNCLASSIFIED SECTION
- principal display panel
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INGREDIENTS AND APPEARANCE
DANDRUFF
selenium sulfide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-816 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) GLYCOL DISTEARATE (UNII: 13W7MDN21W) COCO MONOETHANOLAMIDE (UNII: C80684146D) AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM) SODIUM CITRATE (UNII: 1Q73Q2JULR) AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROGEN PEROXIDE (UNII: BBX060AN9V) HYPROMELLOSES (UNII: 3NXW29V3WO) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-816-15 420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/09/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/09/2012 Labeler - AMAZON.COM SERVICES LLC (128990418) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(72288-816) Establishment Name Address ID/FEI Business Operations RWM TECHNOLOGIES LLC 626626969 manufacture(72288-816)