Label: SELENIUM SULFIDE shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 65255-409-03 - Packager: Sonar Products, 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 January 31, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
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Inactive Ingredients
water, ammonium lauryl sulfate, ammonium laureth sulfate, dihydrogenated tallow phthalic acid amide, sodium chloride, cocamide DEA, dimethicone, aloe barbadensis leaf juice, titanium dioxide, hydroxypropyl methylcellulose, sodium isostearyl lactylate, DMDM hydantoin, fragrance, citric acid, sodium citrate, FD&C blue no.1 (245-067)
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
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INGREDIENTS AND APPEARANCE
SELENIUM SULFIDE
selenium sulfide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65255-409 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO DIETHANOLAMIDE (UNII: 92005F972D) DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G) HYPROMELLOSES (UNII: 3NXW29V3WO) DIMETHICONE (UNII: 92RU3N3Y1O) DMDM HYDANTOIN (UNII: BYR0546TOW) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM CITRATE (UNII: 1Q73Q2JULR) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color TURQUOISE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65255-409-03 325 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358H 02/08/2012 Labeler - Sonar Products, Inc (104283945) Establishment Name Address ID/FEI Business Operations Sonar Products, Inc 104283945 MANUFACTURE(65255-409) , LABEL(65255-409)