SPL v1
SPL
SPL Set ID a7a03fe3-c1a5-5fae-e053-2a95a90ad69d
Route
TOPICAL
Published
Effective Date 2019-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.25 g)
Inactive Ingredients
Water Levomenthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-06-08

Description

Salicylic acid 0.25%


Medication Information

Warnings and Precautions
  • For external use only
  • Seek medical attention if rash, inflammation, itchiness or other symptoms appear during use of the product or after exposure to direct sunlight.
  • Do not use on open wounds
  • Storage and handling precaution
  • Keep out of reach of children
  • Store away from direct sunlight
  • Rinse your eyes with water if they are exposed to the product.
  • Product may cause hair loss or discoloration if not rinsed out thoroughly.
  • Product is slippery. Clean it immediately if dropped on floor.
Indications and Usage

For external use only

Dosage and Administration

Thoroughly wet your hair and scalp.

Lather a proper amount in your palms and work into your hair and scalp. Rinse out with water. Use once a day.

Description

Salicylic acid 0.25%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

Betula Platyphylla Japonica Bark/Biota Orientalis Leaf/Camellia Sinensis Leaf/EcliptaProstrata/Houttuynia Cordata/Lonicera Caprifolium (Honeysuckle)/Luffa Cylindrica Fruit/MorusAlba Fruit/Morus Alba Bark/Morus Alba Leaf/Phellodendron Amurense Bark/PortulacaOleracea/Salvia Miltiorrhiza Root/Sophora Flavescens Extract, Angelica Gigas/Boswellia Serrata/Carthamus Tinctorius (Safflower) Flower/Citrus UnshiuPeel/Cnidium Officinale Rhizome/Commiphora Myrrha Resin/Perilla Frutescens Leaf/PolygonumMultiflorum Root Extract, Glycyrrhiza Uralensis (Licorice) Root/Lespedeza Bicolor Bark/Thuja Orientalis Seed/ViscumAlbum (Mistletoe) Extract, Water, , Sodium Laureth Sulfate, Calcium Oxide, Biotite, Cocamide DEA, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, PEG-120 Methyl Glucose Dioleate, Polyquaternium-10, Purfume, Steartrimonium Chloride, L-Menthol, Arginine, Sulfur, Salicylic Acid, Dimethyl Sulfone, Sodium Benzoate

Section 51945-4

Section 55105-1

helps prevent recurrence of flaking and itching associated with dandruff on scalp

Section 55106-9

Salicylic acid 0.25%


Structured Label Content

Indications and Usage (34067-9)

For external use only

Dosage and Administration (34068-7)

Thoroughly wet your hair and scalp.

Lather a proper amount in your palms and work into your hair and scalp. Rinse out with water. Use once a day.

Warnings and Precautions (34071-1)
  • For external use only
  • Seek medical attention if rash, inflammation, itchiness or other symptoms appear during use of the product or after exposure to direct sunlight.
  • Do not use on open wounds
  • Storage and handling precaution
  • Keep out of reach of children
  • Store away from direct sunlight
  • Rinse your eyes with water if they are exposed to the product.
  • Product may cause hair loss or discoloration if not rinsed out thoroughly.
  • Product is slippery. Clean it immediately if dropped on floor.
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

Betula Platyphylla Japonica Bark/Biota Orientalis Leaf/Camellia Sinensis Leaf/EcliptaProstrata/Houttuynia Cordata/Lonicera Caprifolium (Honeysuckle)/Luffa Cylindrica Fruit/MorusAlba Fruit/Morus Alba Bark/Morus Alba Leaf/Phellodendron Amurense Bark/PortulacaOleracea/Salvia Miltiorrhiza Root/Sophora Flavescens Extract, Angelica Gigas/Boswellia Serrata/Carthamus Tinctorius (Safflower) Flower/Citrus UnshiuPeel/Cnidium Officinale Rhizome/Commiphora Myrrha Resin/Perilla Frutescens Leaf/PolygonumMultiflorum Root Extract, Glycyrrhiza Uralensis (Licorice) Root/Lespedeza Bicolor Bark/Thuja Orientalis Seed/ViscumAlbum (Mistletoe) Extract, Water, , Sodium Laureth Sulfate, Calcium Oxide, Biotite, Cocamide DEA, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, PEG-120 Methyl Glucose Dioleate, Polyquaternium-10, Purfume, Steartrimonium Chloride, L-Menthol, Arginine, Sulfur, Salicylic Acid, Dimethyl Sulfone, Sodium Benzoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

helps prevent recurrence of flaking and itching associated with dandruff on scalp

Section 55106-9 (55106-9)

Salicylic acid 0.25%


Advanced Ingredient Data


Raw Label Data

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