Solimo 816.000/816AC Advanced Solution Dandruff Shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by AMAZON.COM SERVICES LLC, Vi-Jon, LLC, RWM TECHNOLOGIES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DANDRUFF- selenium sulfide shampoo 
AMAZON.COM SERVICES LLC

----------

Solimo 816.000/816AC
Advanced Solution Dandruff Shampoo

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

  • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if 

  • condition worsens or does not improve after regular use as directed

Keep out of reach of children.

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

Directions

  • shake well
  • for maximum dandruff control, use every time you shampoo
  • wet hair,massage onto scalp, rinse, repeat if desired
  • for best results use at least twice a week or as directed by a doctor
  • if used on bleached, gray, tinted or permed hair, rinse for at least 5 minutes

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 Product12/09/201210/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03212/09/201210/05/2021
Labeler - AMAZON.COM SERVICES LLC (128990418)
Registrant - Consumer Product Partners, LLC (119091520)
Establishment
NameAddressID/FEIBusiness Operations
Consumer Product Partners, LLC119091520manufacture(72288-816)
Establishment
NameAddressID/FEIBusiness Operations
Consumer Product Partners, LLC119091514manufacture(72288-816)
Establishment
NameAddressID/FEIBusiness Operations
RWM TECHNOLOGIES LLC626626969manufacture(72288-816)

Revised: 9/2024