URBAN WASH DANDRUFF by Primal Elements

URBAN WASH DANDRUFF by

Drug Labeling and Warnings

URBAN WASH DANDRUFF by is a Otc medication manufactured, distributed, or labeled by Primal Elements. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

URBAN WASH DANDRUFF- pyrithione zinc shampoo 
Primal Elements

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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Active ingredient

Pyrithione zinc 0.3%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product do not get into 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 as directed.

Keep out of reach of children.

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

Directions

shake well 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

Other information

Store at room temperature.

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Styrene/Acrylates Copolymer, Guar Hydroxypropyltrimonium Chloride, Sodium Citrate, Fragrance, Sodium Chloride, Dimethicone, Methylisothiazolinone, Iodopropynyl Butylcarbamate

URBAN WASH DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80801-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DIMETHICONE (UNII: 92RU3N3Y1O)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80801-101-01	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	05/01/2023

Labeler - Primal Elements (968334144)

Revised: 5/2023

Document Id: fb274920-ea6b-386b-e053-6394a90a22e4

34390-5

Set id: fb274920-ea6a-386b-e053-6394a90a22e4

Version: 1

Effective Time: 20230501