ELEMENTZ- pyrithione zinc shampoo

Elementz by

Drug Labeling and Warnings

Elementz by is a Otc medication manufactured, distributed, or labeled by Keefe Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Pyrithione zinc 1%

PURPOSE

Purpose

Antidandruff shampoo

INDICATIONS & USAGE

Uses

helps prevent recurrence of flaking and itching associated with dandruff

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if condition worsens 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 a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Wet hair, massage shampoo into scalp
• rinse and repeat if desired.
• for maximum dandruff control, use at least twice a week or as directed by a doctor

INACTIVE INGREDIENT

Inactive ingredients Water, Sodium Laureth Sulfate, Cocamide DEA, Sodium Chloride, Styrene/Acrylates Copolymer, Coco-Glucoside, Polyquaternium-7, Fragrance, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium Chloride, Citric Acid, Shea Butter, Sweet Almond Oil.

SPL UNCLASSIFIED SECTION

Distributed by:

Keefe Supply Company

Bridgeton, MO 63044

800-325-8998

Made in Colombia

PRINCIPAL DISPLAY PANEL

ELEMENTZ™

WITH MOISTURIZING ALMOND OIL & SHEA BUTTER

PYRITHIONE ZINC

DANDRUFF SHAMPOO

FOR DRY & ITCHY SCALP

15 FL OZ | 443 mL

INGREDIENTS AND APPEARANCE

ELEMENTZ 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51870-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
COCO GLUCOSIDE (UNII: ICS790225B)
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51870-007-15	443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/10/2019

Labeler - Keefe Group (839439601)