85521-002-08

85521-002-08
SPL v1
SPL
SPL Set ID 399fb507-2263-962f-e063-6394a90ae9a8
Route
TOPICAL
Published
Effective Date 2025-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Xanthan Gum Ethylhexylglycerin Sodium Benzoate Coco Monoethanolamide Acrylates Crosspolymer-4 Anhydrous Citric Acid Sodium Hydroxide Water Sodium C14-16 Olefin Sulfonate Cocamidopropylamine Oxide Phenoxyethanol Methyl Gluceth-20 Camellia Sinensis Whole Malus Domestica Whole Argan Oil Panthenol Coconut Oil Cocamidopropyl Betaine Propylene Glycol Edetate Disodium Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Biotin Hydrolyzed Sheep Wool Keratin (2000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-30

Description

Zinc Pyrithione 2%


Medication Information

Warnings and Precautions

For external use only.

Do not use on wounds or damaged skin or on a child under 12 years of age unless directed by a doctor.

Description

Zinc Pyrithione 2%

Use

Helps prevent recurrence of flaking and itching associated with dandruff.

Section 50565-1

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

Section 50566-9

Conditions worsens or does not improve after regular use of this product as directed.

Section 50567-7

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocamide MEA, Methyl Gluceth-20, Polyquaternium-7, Camellia Sinensis Leaf Extract, Malus Domestica Fruit Cell Culture Extract, Argania Spinosa Kernel Oil (Organic), Cocos Nucifera Oil (Organic), Propylene Glycol, Biotin, Hydrolyzed Keratin, Sodium Hydroxide, Xanthan Gum, Sodium Benzoate, Panthenol, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Phenoxyethanol.

Section 55105-1

Anti-Dandruff

Section 55106-9

Zinc Pyrithione 2%

Section 60561-8

See on the bottom of the bottle for lot number and expiration date.

Directions

• Wet hair, massage shampoo into scalp, rinse thoroughly, and repeat if desired.

• For best results, use at least twice a week or as directed by a doctor.

• For maximum dandruff control, use every time you shampoo.

Questions Or Comments?

Call 267-289-3039 or visit www.dandrx.com

Dandrx Anti Dandruff Shampoo


Structured Label Content

Use

Helps prevent recurrence of flaking and itching associated with dandruff.

Warnings and Precautions (34071-1)

For external use only.

Do not use on wounds or damaged skin or on a child under 12 years of age unless directed by a doctor.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Conditions worsens or does not improve after regular use of this product as directed.

Section 50567-7 (50567-7)

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Section 51727-6 (51727-6)

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Cocamide MEA, Methyl Gluceth-20, Polyquaternium-7, Camellia Sinensis Leaf Extract, Malus Domestica Fruit Cell Culture Extract, Argania Spinosa Kernel Oil (Organic), Cocos Nucifera Oil (Organic), Propylene Glycol, Biotin, Hydrolyzed Keratin, Sodium Hydroxide, Xanthan Gum, Sodium Benzoate, Panthenol, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Phenoxyethanol.

Section 55105-1 (55105-1)

Anti-Dandruff

Section 55106-9 (55106-9)

Zinc Pyrithione 2%

Section 60561-8 (60561-8)

See on the bottom of the bottle for lot number and expiration date.

Directions

• Wet hair, massage shampoo into scalp, rinse thoroughly, and repeat if desired.

• For best results, use at least twice a week or as directed by a doctor.

• For maximum dandruff control, use every time you shampoo.

Questions Or Comments? (Questions or comments?)

Call 267-289-3039 or visit www.dandrx.com

Dandrx Anti Dandruff Shampoo (DANDRX ANTI-DANDRUFF SHAMPOO)


Advanced Ingredient Data


Raw Label Data

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