Initial Drug Listing - Probliva Anti-fungal Shampoo

Initial Drug Listing - Probliva Anti-fungal Shampoo
SPL v1
SPL
SPL Set ID 47af9ff8-5d5c-4524-e063-6394a90ac91f
Route
TOPICAL
Published
Effective Date 2026-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (4.72 g)
Inactive Ingredients
Glycerin Citrus Grandis (grapefruit) Peel Oil Diazolidinyl Urea Butylene Glycol Cocamide Mea Panthenol Propylene Glycol Potassium Sorbate Arctium Lappa Whole Water Cocamidopropyl Betaine Sodium Lauryl Sulfate Iodopropynyl Butylcarbamate Disodium Laureth Sulfosuccinate Peg-150 Pentaerythrityl Tetrastearate Peg-6 Caprylic/capric Glycerides Trigonella Foenum-graecum Fruit Hydrolyzed Rice Protein (enzymatic; 2000 Mw) Glycol Stearate Tetrasodium Edta Hedera Helix (ivy) Leaf Water Citric Acid Glycereth-7 Caprylate/caprate Silk Amino Acids Panthenyl Hydroxypropyl Steardimonium Chloride Phenoxyethanol Emu Oil Cocos Nucifera (coconut) Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-20

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 psoriasism
  • Helps reduce scalp itching, flaking, and irritation associatedwith 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 50567-7
  • Avoid contact with eyes. lf contact occurs, rinse thoroughly with water
  • Do not use on broken or severely irritated skin
Section 50569-3
  • Condition worsens or does not improve after regular use
  • lrritation or redness develops
Section 51727-6

Water, Disodium Laureth Sulfosuccinate,Cocamidopropyl Betaine, Cocamide MEA, Glycerin,Tetrasodium EDTA, Hydrolyzed Rice Protein, Butylene Glycol, Panthenol,Pantheny Ilydroxypropyl Steardimo-nium Chloride,Aretium Lappa Root Extract,Hedera Helix(Ivy) Extract,Trigonella Foenum-Graecum Seed Extract,Phenoxyethanol, Potassium Sorbate,Emu Oi, Cocos Nucifera(Coconut)Oil,Silk Amino Acids,Citrus Grandis (Grapefruit) Seed Extract, Sodium Lauryl Sulfate, Glycol Stearate, Panthenol, PropyleneGlycol,Diazolidinyl Urea, lodopropyny Butylcarbamate, Fragrance, Ciuric Acid,PEG-150 Pentaerythrityl tetrastearate (and)PEG-6 Capric/Caprylic glycerides

Section 51945-4

Section 53413-1
Section 55105-1

Anti-dandruff,seborrheic dermatitis,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 psoriasism
  • Helps reduce scalp itching, flaking, and irritation associatedwith 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 50567-7 (50567-7)
  • Avoid contact with eyes. lf contact occurs, rinse thoroughly with water
  • Do not use on broken or severely irritated skin
Section 50569-3 (50569-3)
  • Condition worsens or does not improve after regular use
  • lrritation or redness develops
Section 51727-6 (51727-6)

Water, Disodium Laureth Sulfosuccinate,Cocamidopropyl Betaine, Cocamide MEA, Glycerin,Tetrasodium EDTA, Hydrolyzed Rice Protein, Butylene Glycol, Panthenol,Pantheny Ilydroxypropyl Steardimo-nium Chloride,Aretium Lappa Root Extract,Hedera Helix(Ivy) Extract,Trigonella Foenum-Graecum Seed Extract,Phenoxyethanol, Potassium Sorbate,Emu Oi, Cocos Nucifera(Coconut)Oil,Silk Amino Acids,Citrus Grandis (Grapefruit) Seed Extract, Sodium Lauryl Sulfate, Glycol Stearate, Panthenol, PropyleneGlycol,Diazolidinyl Urea, lodopropyny Butylcarbamate, Fragrance, Ciuric Acid,PEG-150 Pentaerythrityl tetrastearate (and)PEG-6 Capric/Caprylic glycerides

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Anti-dandruff,seborrheic dermatitis,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

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