MIELLE LAVENDER AND LYCHEE SCALP SOOTHING DAILY REFRESHER- pyrithione zinc lotion

Drug Labeling and Warnings

Drug Details [pdf]

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Drug Facts

Active ingredient

Pyrithione zinc 0.1%

Purpose

Antidandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When using this product

• avoid contact with 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 of this product as directed.

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

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Distributed by:

Mielle Organics, LLC

Merrillville, IN 46410

www.mielleorganics.com

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Mielle

Pyrithione Zinc

Dandruff Treatment

LAVENDER

& LYCHEE

SCALP SOOTHING

DAILY REFRESHER

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

MIELLE LAVENDER AND LYCHEE SCALP SOOTHING DAILY REFRESHER 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LITCHI FRUIT (UNII: Y5P61KP51E)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PEPPERMINT (UNII: V95R5KMY2B)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
TETRAHYDROXYPROPYL ETHYLENEDIAMINE (UNII: Q4R969U9FR)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER (UNII: 19AH1RAF4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)
MENTHOL (UNII: L7T10EIP3A)
CAFFEINE (UNII: 3G6A5W338E)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-257-11	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	03/01/2026

Labeler - The Procter & Gamble Manufacturing Company (004238200)