ZINCON MEDICATED DANDRUFF- pyrithione zinc shampoo

Zincon Medicated Dandruff by

Drug Labeling and Warnings

Zincon Medicated Dandruff by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Pyrithione zinc 1%

(To the right)

Purpose

Anti-dandruff

Uses

• Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis.

Warnings:

• For external use only.

Ask a doctor before use if you

have a condition that covers a large area of the body.

When using this product 

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if:

• Condition worsens
  
• Condition does not improve after regular use of this product as directed.

Keep out of reach of children:

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

Directions:

• Shake well
  
• Wet hair, apply shampoo and work into lather
  
• Rinse thoroughly
  
• For best results, use at least twice a week or as directed by a doctor
  
• Do not use on children under 2 years of age, except as directed by a doctor

Inactive Ingredients

Citric acid, cocamide MEA, deionized water, FD & C Blue No. 1, Fragrance, glycol distearate, magnesium aluminum silicate, methylchloroisothiazolinone, methylisothiazolinone, propylene glycol, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate.

Questions? 1-800-220-0151

Manufactured for Neoteric Cosmetics, Inc.

Denver, CO 80239

WWW. Neotericcosmetics.com MADE IN USA

PRINCIPAL DISPLAY PANEL

Pyrithione Zinc
ZINCON
MEDICATED
DANDRUFF SHAMPOO

• Controls dandruff itching & flaking
  
• Leaves hair clean & easy to manage
  
• Pleasant fragrance

4 fl.oz. (118ml)

PRINCIPAL DISPLAY PANEL

Pyrithione Zinc
ZINCON
MEDICATED
DANDRUFF SHAMPOO

• Controls dandruff itching & flaking
  
• Leaves hair clean & easy to manage
  
• Pleasant fragrance

8 fl.oz. (236ml)

INGREDIENTS AND APPEARANCE

ZINCON MEDICATED DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62673-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62673-016-94	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2017
2	NDC: 62673-016-98	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	12/13/2017

Labeler - Neoteric Cosmetics, Inc. (790615181)