Anti-Dandruff Zinc Shampoo

Progenesis by

Drug Labeling and Warnings

Progenesis by is a Otc medication manufactured, distributed, or labeled by Palcare Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROGENESIS- anti-dandruff shampoo shampoo 
Palcare Enterprises Inc

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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Anti-Dandruff Zinc Shampoo

Active Ingredient(s)

Zinc Pyrithione..... 0.5%

Purpose

Anti-Dandruff

Use

Removes thin and dry dandruff flakes, nourishes and moisturizes the scalp.

Warnings

• For external use only
• In case of eye contact, wash immediately

Do not use

Do not use it on an open wounds or cuts

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

Directions

Wet hair with warm water,

Apply 4-5 drops of the product,

Massage gently into the lather of your scalp and hair and allow to act for a few minutes

Subsequently rinse accurately.

Questions (or comments)? Call 1-250-590-4850

Inactive ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, PEG-150 pentaerythrityl tetrastearate, PPG-2 hydroxyethyl cocamide, sodium benzoate polysorbate 20, parfum, citric acid, cocamide DEA, piroctone olamine, sodium naphthalenesulfonate, capsicum frutescens fruit extract, propylene glycol, achillea millefolium extract, 1,2-hexanediol, sodium cocoamphoacetate, polyquaternium-7, dipropylene glycol, propanediol, panthenol, potassium sorbate, glycerin, sodium chloride

Package Label - Principal Display Panel

250 mL NDC: 82349-139-65

PROGENESIS 
anti-dandruff shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82349-139
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PENTAERYTHRITYL TETRASTEARATE (UNII: W9Q3DZS0EG)
SODIUM NAPHTHALENESULFONATE (UNII: D3F8YRX7TP)
TABASCO PEPPER (UNII: J1M3NA843L)
PROPANEDIOL (UNII: 5965N8W85T)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-150 LANOLIN (UNII: 8WTH94XZF2)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82349-139-65	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2022	02/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/01/2022	02/10/2023

Labeler - Palcare Enterprises Inc (204341445)

Establishment
Name	Address	ID/FEI	Business Operations
Palcare Enterprises Inc		204341445	manufacture(82349-139)

Revised: 7/2023

Document Id: ffa24e1a-9d56-f43e-e053-6394a90a8018

34390-5

Set id: d2039edf-8962-0bca-e053-2995a90a17d6

Version: 3

Effective Time: 20230703