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Distributed by:
Mielle Organics, LLC
Merrillville, IN 46410
www.mielleorganics.com
Mielle Lavender And Lychee Scalp Soothing Daily Refresher Lotion
FDA Label NDC 84126-257
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Mielle Lavender And Lychee Scalp Soothing Daily Refresher (NDC 84126-257). 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 other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Pyrithione zinc 0.1%
Purpose
Antidandruff
Uses
helps prevent recurrence of flaking and itching associated with dandruff
Warnings
For external use only
Otc - When Using
When using this product
- avoid contact with 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 of this product as directed.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply to affected areas one to four times daily or as directed by a doctor.
- section hair if needed. Remove cap and place nozzle directly onto the scalp
- pump to cover entire section of exposed scalp (may take 3 or more pumps) Massage into scalp.
- repeat to cover your entire scalp. Do not rinse.
Inactive Ingredients
Water, niacinamide, PEG-40 hydrogenated castor oil, phenoxyethanol, caffeine, fragrance, bis PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, benzyl alcohol, menthol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin, litchi chinensis fruit extract, mentha arvensis leaf/stem oil, mentha piperita (peppermint) flower/leaf/stem oil, lavandula angustifolia (lavender) flower extract
Questions (Or Comments)?
1-800-436-9165
Principal Display Panel - 118 Ml Bottle Label
Mielle
Pyrithione Zinc
Dandruff Treatment
LAVENDER
& LYCHEE
SCALP SOOTHING
DAILY REFRESHER
4 FL OZ (118 mL)
Mielle (Mielle)
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