APEX CROWN ANTI DANDRUFF- pyrithione zinc shampoo

Apex Crown Anti Dandruff by

Drug Labeling and Warnings

Apex Crown Anti Dandruff by is a Otc medication manufactured, distributed, or labeled by Restoration Rockstar LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Zinc Pytithione 2.00%

Purpose section

Anti Dandruff

Uses:

• Helps prevent and control recurring flaking and itching associated with dandruff.

Directions:

• Wet your hair and massage shampoo onto your hair and scalp, then rinse. Repeat if desired.

Warnings:

For external scalp use only.

Do not use

if you have any allergy to any ingredients in this product, or on a scalp that has an active wound or inflammation

• avoid all eye contact if eye contact occurs, rinse meticulously with water.

Stop use & consult a doctor

if rash appears on scalp or condition does not improve within one month.

Keep out of reach of children

If the shampoo is orally consumed, get medical attention and contact a poison control center.

If pregnant or breastfeeding

consult a doctor before use.

Inactive Ingredients:

Aqua (Deionized Water), Calendula Officinalis (Marigold) Flower Extract, Chamaemelum Nobile (Roman Chamomile) Oil Extract, Chamomilla Recutita (Matricaria) Extract, Cocamidopropyl Betaine, DL-Panthenol, Gluconolactone, Glycerin, Hydrolyzed Keratin, Lauryl Glucoside, Melaleuca Alternifolia (Australian Tea Tree) Leaf Oil Parfum (Fragrance), Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officianlia (Sage) Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Cocoly Isethionate, Xanthan Gum

Product Label

INGREDIENTS AND APPEARANCE

APEX CROWN ANTI DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69882-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PANTHENOL (UNII: WV9CM0O67Z)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
ROSEMARY (UNII: IJ67X351P9)
SAGE (UNII: 065C5D077J)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69882-023-01	1 in 1 CARTON	02/02/2017
1		354.88 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/29/2015

Labeler - Restoration Rockstar LLC (071268228)