Dermazinc Cream

Dermazinc Cream
SPL v4
SPL
SPL Set ID e72e54ba-03fe-6748-e053-2a95a90a196f
Route
TOPICAL
Published
Effective Date 2022-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.25 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Peg-75 Lanolin Aloe Vera Leaf Carbomer 980 Cetyl Alcohol Dimethicone 200 Glyceryl Stearate Se Stearic Acid Methylparaben Dmdm Hydantoin Mineral Oil Water Isopropyl Palmitate Trolamine Undecylenic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-29

Description

Pyrithione Zinc 0.25%


Medication Information

Warnings and Precautions

Warnings

■ For external use only.

■ Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product avoid contact with the 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.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

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

Indications and Usage

For relief of the symptoms of seborrheic dermatitis.

Dosage and Administration

Apply to affected area twice daily or as directed by a doctor.

Description

Pyrithione Zinc 0.25%

Section 50565-1

Keep Out of Reach of Children.

Section 51727-6

Inactive ingredients aloe barbadensis leaf (aloe vera gel) juice, carbomer, cetyl

alcohol, dimethicone, DMDM hydantoin, glyceryl stearate, isopropyl palmitate, methylparaben,

mineral oil, PEG-75 lanolin, sodium 1auryl sulfate, stearic acid, tocopheryl acetate (vitamin E),

triethanolamine,undecylenic acid, water

Section 51945-4

Section 55105-1

Seborrheic Dermatitis treatment

Section 55106-9

Pyrithione Zinc 0.25%


Structured Label Content

Indications and Usage (34067-9)

For relief of the symptoms of seborrheic dermatitis.

Dosage and Administration (34068-7)

Apply to affected area twice daily or as directed by a doctor.

Warnings and Precautions (34071-1)

Warnings

■ For external use only.

■ Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product avoid contact with the 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.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

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

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51727-6 (51727-6)

Inactive ingredients aloe barbadensis leaf (aloe vera gel) juice, carbomer, cetyl

alcohol, dimethicone, DMDM hydantoin, glyceryl stearate, isopropyl palmitate, methylparaben,

mineral oil, PEG-75 lanolin, sodium 1auryl sulfate, stearic acid, tocopheryl acetate (vitamin E),

triethanolamine,undecylenic acid, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Seborrheic Dermatitis treatment

Section 55106-9 (55106-9)

Pyrithione Zinc 0.25%


Advanced Ingredient Data


Raw Label Data

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