DANDRUFF- selenium sulfide shampoo 
AMAZON.COM SERVICES LLC

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.

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Advanced Solution Dandruff Shampoo
816.000/816AC

Active ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Use

helps prevent recurrence of itching, irritation, redness, flaking and scaling associated with dandruff and seborrheic dermatitis

Warnings

For external use only

Ask a doctor before use if

condition covers a large area of the body

When using this product

Stop use and ask a doctor if 

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

DISTRIBUTED BY:

Amazon.com, Services, LLC

Seattle, WA 98109

1-877-485-0385

2021 Amazon.com, Inc. or its affiliates.

All rights reserved.

Amazon.com, Inc or its affiliates.

816.000/816AC

principal display panel

Solimo dandruff shampoo

Selenium sulfide 1%

Maximum strength

14.2 FL OZ (420 mL)

image description

DANDRUFF 
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-816
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-816-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/09/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/09/2012
Labeler - AMAZON.COM SERVICES LLC (128990418)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72288-816)
Establishment
NameAddressID/FEIBusiness Operations
RWM TECHNOLOGIES LLC626626969manufacture(72288-816)

Revised: 1/2023
Document Id: d39bbd1c-fba8-4691-aec9-5a536eab1f38
Set id: 3af03d59-d18b-4206-9f21-6abc0fec1956
Version: 2
Effective Time: 20230112
 
AMAZON.COM SERVICES LLC