The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Everyday Clean Dandruff (NDC 36800-153). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active IngredientPyrithione Zinc
Otc - Purpose
PurposeAnti-dandruff
Indications & Usage
Use help prevent recurrence of flaking and itching associated with dandruff
Warnings
WarningsFor External use only
Otc - When Using
When using this product•do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if•condition worsens or does not improve after regular use as directed
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help orcontact a Poison Control center right away
Dosage & Administration
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 tice a week or as directed by a doctor
Inactive Ingredient
Inactive ingredients water, sodium laureth
sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate,glycol
distearate, amodimethicone, fragrance, cetyl alcohol,guar
hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate,
magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl
alcohol, sodium chloride,methylchloroisothiazolinone,
methylisothiazolinone, sodium xylenesulfonate, trideceth-12,
cetrimonium chloride, citric acid, yellow 10, blue 1, red 4
Other
This product is not manufactured or distributed by Procter + Gamble, distributor of Head + Shoulders
Adverse Reactions
Distributed By Topco Associates LLC7711 Gross Point roadSkokie, Il 60077Questions 1-888-423-0139topcare@topco. com
Package Label.Principal Display Panel
TopCareGENTLEdandruffshampoowith pyrithione zincgentle and pH balanced foreveryday use, even for permedor color-treated hairEVERYDAY CLEANCompare to Head + Shoulders
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