Anti-Dandruff Sulfur & Salicylic 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- dandruff and seborrheic dermatitis 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 Sulfur & Salicylic Shampoo

Active Ingredient(s)

Sulfur................2% Dandruff, seborrheic

Salicylic Acid.....2% Dermatitis shampoo

Purpose

Dandruff, seborrheic and dermatitis shampoo

Use

Helps stop the symptoms of dandruff & seborrheic dermatitis

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, parfum, polysorbate 20, citric acid, cocamide DEA, caffeine, cinchona pubescens bark, plantago lanceolata leaf extract, hedera helix extract, Biotin, 1,2-hexanediol, sodium, cocoamphoaceate, polyquaternium-7, dipropylene glycol, propanediol, panthenol, potassium sorbate, glycerin, sodium chloride, PEG-30 castor Oil

Package Label - Principal Display Panel

250 mL NDC: 82349-140-72

PROGENESIS 
dandruff and seborrheic dermatitis shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82349-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg  in 100 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITYL TETRASTEARATE (UNII: W9Q3DZS0EG)
CINCHONA PUBESCENS BARK (UNII: S96N10R972)
PROPANEDIOL (UNII: 5965N8W85T)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-150 LANOLIN (UNII: 8WTH94XZF2)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
CAFFEINE (UNII: 3G6A5W338E)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
BIOTIN (UNII: 6SO6U10H04)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PANTHENOL (UNII: WV9CM0O67Z)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYOXYL 30 CASTOR OIL (UNII: GF873K38RZ)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82349-140-72	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(82349-140)

Revised: 7/2023

Document Id: ffa21fac-a723-11bb-e053-6394a90acc04

34390-5

Set id: d204d436-4e21-0229-e053-2a95a90ac688

Version: 3

Effective Time: 20230703