SPL v1
SPL
SPL Set ID a7a03fe3-c1a8-5fae-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
  • Do not use on children under 3 years of age.
  • Rinse your eyes with water if they are exposed to the product.
  • Those who have had allergic symptoms should consult a doctor and pharmacist before use.
  • Those who are hypersensitive to salicylic acid or have diabetes, blood circulation disorders, kidney failure, infection, redness, etc., and who are on their period, are pregnant or may be pregnant should not use it because the current symptoms are likely to worsen after use, such as hypersensitive skin or body or an abnormal skin reaction (edema, inflammation, etc.).
Indications and Usage

For external use only

Dosage and Administration

Shake the product thoroughly before use, apply an appropriate amount evenly on the scalp, and rub it with your fingers to absorb it as if massaging.

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, Alcohol, Biotite, Glycerin, Polysorbate 80, PEG-60 Hydrogenated Castor Oil, Citric Acid, Sodium Benzoate, L-Menthol, Salicylic Acid, Dimethyl Sulfone, Arginine, Dexpanthenol, Sulfur, Disodium EDTA

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)

Shake the product thoroughly before use, apply an appropriate amount evenly on the scalp, and rub it with your fingers to absorb it as if massaging.

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
  • Do not use on children under 3 years of age.
  • Rinse your eyes with water if they are exposed to the product.
  • Those who have had allergic symptoms should consult a doctor and pharmacist before use.
  • Those who are hypersensitive to salicylic acid or have diabetes, blood circulation disorders, kidney failure, infection, redness, etc., and who are on their period, are pregnant or may be pregnant should not use it because the current symptoms are likely to worsen after use, such as hypersensitive skin or body or an abnormal skin reaction (edema, inflammation, etc.).
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, Alcohol, Biotite, Glycerin, Polysorbate 80, PEG-60 Hydrogenated Castor Oil, Citric Acid, Sodium Benzoate, L-Menthol, Salicylic Acid, Dimethyl Sulfone, Arginine, Dexpanthenol, Sulfur, Disodium EDTA

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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