drug facts

drug facts
SPL v1
SPL
SPL Set ID 9e5835e9-28d1-44ef-828d-af5a6c04ea78
Route
topical
Published
Effective Date 2011-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pyrithione zinc (1 mL)
Inactive Ingredients
water sodium laureth sulfate sodium lauryl sulfate coco monoethanolamide zinc carbonate glycol distearate dimethicone cetyl alcohol polyquaternium-10 (400 cps at 2%) magnesium sulfate, unspecified sodium benzoate menthol polyethylene glycol 7000 magnesium carbonate hydroxide ammonium laureth-3 sulfate sea salt fucus vesiculosus benzyl alcohol sodium chloride methylchloroisothiazolinone methylisothiazolinone sodium xylenesulfonate fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2011-12-23

Purpose

ANTI-DANDRUFF

Description

PYRITHIONE ZINC 1%


Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

Purpose

ANTI-DANDRUFF

Directions

FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO

WET HAIR, MASSAGE ONTO SCALP, RINSE, REPEAT IF DESIRED

FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED  BY A DOCTOR

Inactive Ingredients

WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE DEA, ZINC CARBONATE, GLYCOL DISTEARATE, FRAGRANCE, DIMETHICONE, CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MENTHOL, PEG-7M, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, SEA SALT, FUCUS  VESICULOSUS EXTRACT, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE,  SODIUM XYLENE SULFONATE, BLUE 1, YELLOW 5

Description

PYRITHIONE ZINC 1%

Label Copy

Active Ingredient

PYRITHIONE ZINC 1%

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Stop Use and Ask A Doctor If

CONDITION WORSONS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

Keep Out of Reach of Children

IF SWALLOWED GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY


Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Uses (USES)

HELPS PREVENT RECURRENCE OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF

Purpose (PURPOSE)

ANTI-DANDRUFF

Directions (DIRECTIONS)

FOR MAXIMUM DANDRUFF CONTROL, USE EVERY TIME YOU SHAMPOO

WET HAIR, MASSAGE ONTO SCALP, RINSE, REPEAT IF DESIRED

FOR BEST RESULTS USE AT LEAST TWICE A WEEK OR AS DIRECTED  BY A DOCTOR

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE DEA, ZINC CARBONATE, GLYCOL DISTEARATE, FRAGRANCE, DIMETHICONE, CETYL ALCOHOL, POLYQUATERNIUM-10, MAGNESIUM SULFATE, SODIUM BENZOATE, MENTHOL, PEG-7M, MAGNESIUM CARBONATE HYDROXIDE, AMMONIUM LAURETH SULFATE, SEA SALT, FUCUS  VESICULOSUS EXTRACT, BENZYL ALCOHOL, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE,  SODIUM XYLENE SULFONATE, BLUE 1, YELLOW 5

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

PYRITHIONE ZINC 1%

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

CONDITION WORSONS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IF SWALLOWED GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY


Advanced Ingredient Data


Raw Label Data

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