Elementz Dandruff Shampoo

Drug Labeling and Warnings

Drug Details [pdf]

ELEMENTZ- pyrithione zinc shampoo 
Keefe Group

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Elementz Dandruff Shampoo

Drug Facts:

Active Ingredient

Pyrithione Zinc 1.2%

Purpose

Anti dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings using this product

For external use only.

When using this product

• avoid contact with 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.

Directions:

For maximum dandruff control, use at least twice a week. Wet hair, massage through hair and scalp, rinse and repeat if desired.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS:

Water (Aqua), Sodium Laureth Sulfate, Glycol Distearate, Sodium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea Butter), Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone.

Distributed by: Olivette Products, L.L.C., Bridgeton, MO 63044

ELEMENTZ™

FOR MEN

ALMOND & SHEA BUTTER

DANDRUFF SHAMPOO

FOR DRY & ITCHY SCALP

15 FL OZ | 443 mL

​

ELEMENTZ 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51870-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALMOND OIL (UNII: 66YXD4DKO9)
SHEA BUTTER (UNII: K49155WL9Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51870-002-15	443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2017	10/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/30/2017	10/21/2019

Labeler - Keefe Group (839439601)

Registrant - Willard Manufacturing Inc. (208799143)

Establishment
Name	Address	ID/FEI	Business Operations
Willard Manufacturing Inc.		208799143	manufacture(51870-002)

Revised: 10/2019

Document Id: 95717a64-1f23-0ad6-e053-2995a90ab53b

34390-5

Set id: 47558574-5b78-6e95-e054-00144ff8d46c

Version: 2

Effective Time: 20191021