MIELLE LAVENDER AND LYCHEE SCALP MOISTURIZING- pyrithione zinc shampoo

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

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

• for best results use at least twice a week or as directed by a doctor.
• shake before use
• wet hair thoroughly, massage gently into scalp and hair for 1-2 minutes. Rinse and repeat if desired.

Inactive Ingredients

Water, lauramidopropyl betaine, sodium cocoyl isethionate, sodium lauroyl sarcosinate, fragrance, dimethiconol, sodium chloride, sodium citrate, acrylates copolymer, TEA-dodecylbenzenesulfonate, polyquaternium-10, sodium benzoate, citric acid, laureth-23, sodium salicylate, niacinamide, litchi chinensis fruit extract, lavandula angustifolia (lavender) flower extract

Questions (or comments)?

1-800-436-9165

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DISTRIBUTED BY:

Mielle Organics. LLC

Merrillville, IN 46410

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

Mielle
PYRITHIONE ZINC

DANDRUFF SHAMPOO

LAVENDER

& LYCHEE

SCALP MOISTURIZING

SHAMPOO

12.0 FL OZ
(355 mL)

INGREDIENTS AND APPEARANCE

MIELLE LAVENDER AND LYCHEE SCALP MOISTURIZING 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONOL (50000 CST) (UNII: R2285D73YT)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER (UNII: 19AH1RAF4M)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
LAURETH-23 (UNII: N72LMW566G)
LITCHI FRUIT (UNII: Y5P61KP51E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-256-35	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2026

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

Labeler - The Procter & Gamble Manufacturing Company (004238200)