Initial Drug Listing - Hermon Folliculitis Shampoo

Initial Drug Listing - Hermon Folliculitis Shampoo
SPL v1
SPL
SPL Set ID 3c5f7caa-a4af-2574-e063-6394a90a7507
Route
TOPICAL
Published
Effective Date 2025-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (8 g)
Inactive Ingredients
Piroctone Olamine Serine Biotin Niacinamide Sodium Benzoate Saw Palmetto Sodium Lauroamphoacetate Sodium Methyl Cocoyl Taurate Decyl Glucoside Panax Ginseng Root Melaleuca Alternifolia (tea Tree) Leaf Oil Centella Asiatica Platycladus Orientalis Leaf Sodium Chloride Peg-150 Distearate Sodium Laureth-6 Carboxylate Rosmarinus Officinalis (rosemary) Leaf Oil Cocamidopropyl Betaine Ppg-10 Caprylyl Ether Cyclodextrin Lactic Acid Water Tetrasodium Glutamate Diacetate Polyquaternium-10 (1000 Mpa.s At 2%) Maltodextrin Polyquaternium-11 (1000000 Mw) Sodium Cocoyl Glutamate Hydroxypropyl Guar Hydroxypropyltrimonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-31
Description

Salicylic Acid 2%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Apply to wet hair and scalp
  • Massage gently into scalp for 1-2 minutes
  • Rinse thoroughly
  • Use at least twice per week or as directed by a doctor
Dosage and Administration
  • Helps control dandruff, seborrheic dermatitis, and psoriasis
  • Helps reduce scalp itching, flaking, andirritation associated with dandruff, seborrheic dermatitis, and psoriasis
Description

Salicylic Acid 2%

Section 50565-1

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

Section 50566-9
  • Condition worsens or does not improve after regular use
  • lrritation or redness develops
Section 50567-7
  • Avoid contact with eyes. lf contactoccurs, rinse thoroughly with water
  • Do not use on broken or severely irritated skin
Section 51727-6

Water, Cocamidopropyl Betaine, Niacinamide, Centella Asiatica Leaf Extract, Thuja Orientalis Leaf Extract, Serenoa Serrulata Fruit Extract,Sodium Chloride, Cyclodextrin, Sodium Methyl Cocoyl Taurate, Sodium Lauroamphoacetate, Decyl Glucoside, Panax Ginseng Root Extract,Melaleuca Alternifolia (Tea Tree) Leaf Oil.Caffeine, PEG-150 Distearate, Lactic Acid, PPG-3 Caprylyl Ether, Piroctone Olamine,Biotin, Sodium Cocoyl Glutamate, Sodium Laureth-6 Carboxylate, Sodium Benzoate,Olive Oil PEG-7 Esters, Polyquaternium-10.Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydroxypropyl Guar HydroxypropyltrimoniumChloride,Maltodextrin,Tetrasodium Glutamate Diacetate, Polyquaternium-11. Serine

Section 51945-4

Section 53413-1

[email protected]

Section 55105-1

Anti-dandruff, seborrheicdermatitis, and psoriasis

Section 55106-9

Salicylic Acid 2%

Section 60561-8

Store at 15°-30°C(59°-86°F)

Structured Label Content

Indications and Usage (34067-9)
  • Apply to wet hair and scalp
  • Massage gently into scalp for 1-2 minutes
  • Rinse thoroughly
  • Use at least twice per week or as directed by a doctor
Dosage and Administration (34068-7)
  • Helps control dandruff, seborrheic dermatitis, and psoriasis
  • Helps reduce scalp itching, flaking, andirritation associated with dandruff, seborrheic dermatitis, and psoriasis
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)
  • Condition worsens or does not improve after regular use
  • lrritation or redness develops
Section 50567-7 (50567-7)
  • Avoid contact with eyes. lf contactoccurs, rinse thoroughly with water
  • Do not use on broken or severely irritated skin
Section 51727-6 (51727-6)

Water, Cocamidopropyl Betaine, Niacinamide, Centella Asiatica Leaf Extract, Thuja Orientalis Leaf Extract, Serenoa Serrulata Fruit Extract,Sodium Chloride, Cyclodextrin, Sodium Methyl Cocoyl Taurate, Sodium Lauroamphoacetate, Decyl Glucoside, Panax Ginseng Root Extract,Melaleuca Alternifolia (Tea Tree) Leaf Oil.Caffeine, PEG-150 Distearate, Lactic Acid, PPG-3 Caprylyl Ether, Piroctone Olamine,Biotin, Sodium Cocoyl Glutamate, Sodium Laureth-6 Carboxylate, Sodium Benzoate,Olive Oil PEG-7 Esters, Polyquaternium-10.Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydroxypropyl Guar HydroxypropyltrimoniumChloride,Maltodextrin,Tetrasodium Glutamate Diacetate, Polyquaternium-11. Serine

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

[email protected]

Section 55105-1 (55105-1)

Anti-dandruff, seborrheicdermatitis, and psoriasis

Section 55106-9 (55106-9)

Salicylic Acid 2%

Section 60561-8 (60561-8)

Store at 15°-30°C(59°-86°F)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:53.071554 · Updated: 2026-03-14T23:09:55.704959