SPL v1
SPL
SPL Set ID f883af96-9aaf-4d83-9905-0d2b27e511c2
Route
TOPICAL
Published
Effective Date 2023-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1 g)
Inactive Ingredients
Water Sodium Laureth-3 Sulfate Sodium Lauryl Sulfate Cocamidopropyl Betaine Coco Monoethanolamide Glycol Stearate Sodium Xylenesulfonate Sodium Chloride Zinc Carbonate Dimethicone Cetrimonium Chloride Sodium Benzoate Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Magnesium Carbonate Hydroxide Citric Acid Monohydrate Almond Oil Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-03-15

Description

 Pyrithione Zinc 1%

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff

Description

 Pyrithione Zinc 1%

Use

helps protect the scalp's natural moisture balance and gives you great looking hair.   

Section 42229-5

Distributed By:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

Made in India

Warnings

For external use only.

Directions
  • shake well. Wet hair. Massage onto scalp. Rinse. 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.
Product Label

Active Ingredient

 Pyrithione Zinc 1%

Inactive Ingredients

Water, Sodium lauryl Ether Sulfate, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Cocomonoethanolamide, Ethylene Glycol Monostearate, Sodium Xylenesulfonate, Sodium Chloride, Zinc Carbonate, Dimethicone, Cetrimonium Chloride, Fragrance, Sodium Benzoate, Gaur Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Citric Acid, Prunus Amygdalus dulcis ( Sweet Almond )Oil, Methylchloroisothiazolinone, Methylisothiazolinone, FD & C Blue No. 1, Cl No. 42090

When Using This Product

do not get into 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 as directed.

Keep Out of Reach of Children

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


Structured Label Content

Use

helps protect the scalp's natural moisture balance and gives you great looking hair.   

Section 42229-5 (42229-5)

Distributed By:

PRESTIGE BEAUTY CARE

1585 West Mission Blvd.

Pomona, CA 91766

Made in India

Purpose

Anti-dandruff

Warnings

For external use only.

Directions
  • shake well. Wet hair. Massage onto scalp. Rinse. 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.
Product Label (Product label)

Active Ingredient

 Pyrithione Zinc 1%

Inactive Ingredients

Water, Sodium lauryl Ether Sulfate, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Cocomonoethanolamide, Ethylene Glycol Monostearate, Sodium Xylenesulfonate, Sodium Chloride, Zinc Carbonate, Dimethicone, Cetrimonium Chloride, Fragrance, Sodium Benzoate, Gaur Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Citric Acid, Prunus Amygdalus dulcis ( Sweet Almond )Oil, Methylchloroisothiazolinone, Methylisothiazolinone, FD & C Blue No. 1, Cl No. 42090

When Using This Product (When using this product)

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or does not improve after regular use as directed.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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