SPL v32
SPL
SPL Set ID 440a3a73-7136-f8b2-e063-6394a90a744d
Route
TRANSDERMAL
Published
Effective Date 2025-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Albizia Julibrissin Flower Caprylhydroxamic Acid Rosmarinus Officinalis (rosemary) Leaf Oil Butylene Glycol Helianthus Annuus (sunflower) Seed Oil Glyceryl Stearate Saposhnikovia Divaricata Root Triticum Vulgare (wheat) Germ Water Alfuzosin Hydroxy Acid Bisabolol Niacinamide Ethylhexylglycerin Centella Asiatica 1,2-hexanediol Panthenol Hyaluronic Acid Gastrodia Elata Tuber Pentylene Glycol Trehalose Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Polysorbate 80 Opuntia Ficus-indica Astragalus Propinquus Root Sorbitan Oleate Dimethyl Isosorbide Glycerin Cetearyl Alcohol Calendula Officinalis Flower Isohexadecane Cetyl Ethylhexanoate Peg-100 Stearate Starch, Tapioca

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-21

Description

Salicylic Acid


Medication Information

Warnings and Precautions

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Indications and Usage

DIRECTIONS

• Gently cleanse your face with a mild cleanser and pat dry using a clean towel before applying the gel.

• Apply a thin, even layer of the gel directly to the affected areas using clean fingertips, avoiding unbroken or irritated skin.

• Begin with once-daily use, preferably in the evening, and gradually increase to twice daily (morning and evening) as your skin adjusts.

• Allow the gel to fully absorb before applying additional products to ensure optimal effectiveness.

• Discontinue use if irritation, redness, or allergic reaction occurs, and consult a healthcare professional if necessary.

Dosage and Administration

DIRECTIONS

• Gently cleanse your face with a mild cleanser and pat dry using a clean towel before applying the gel.

• Apply a thin, even layer of the gel directly to the affected areas using clean fingertips, avoiding unbroken or irritated skin.

• Begin with once-daily use, preferably in the evening, and gradually increase to twice daily (morning and evening) as your skin adjusts.

• Allow the gel to fully absorb before applying additional products to ensure optimal effectiveness.

• Discontinue use if irritation, redness, or allergic reaction occurs, and consult a healthcare professional if necessary.

Description

Salicylic Acid

Section 50565-1

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Section 50566-9

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Section 50567-7

Time of day:

24 HOURS

Routine Order:

Cleanse • Treatment • Moisturize

Section 50570-1

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Section 51945-4

label

Section 55105-1

KEY BENEFITS

• Acne Control & Pore Cleansing:

Salicylic Acid and Beta Hydroxy Acid exfoliate the skin, clear pores, and remove excess oil, effectively reducing and preventing acne.

• Anti-inflammatory & Skin Soothing:

Bisabolol and Centella Asiatica Extract have anti-inflammatory properties to soothe irritation, reduce redness, and calm the skin.

• Hydration & Moisture Retention:

Hyaluronic Acid, Glycerin, and Panthenol attract and retain moisture, providing long-lasting hydration without clogging pores.

• Reduces Hyperpigmentation & Skin Tone Evening:

Niacinamide brightens skin, evens tone, and reduces acne scars and hyperpigmentation.

• Antioxidant Protection & Skin Repair:

Plant extracts like Astragalus Root, Calendula, and Rosemary provide antioxidants, support repair, and enhance skin resilience.

• Strengthens Skin Barrier:

Wheat Germ Ferment Filtrate and Sunflower Seed Oil nourish and strengthen the skin barrier, preventing moisture loss and protecting against irritants.

• Gentle yet Effective:

The formula is gentle while effectively treating acne, balancing oil production without over-drying.

Active Ingredient

Salicylic Acid

Inactive Ingredients

Inactive Ingredients



Water, Butylene Glycol, Triticum Vulgare (Wheat) Germ Ferment Filtrate, Beta Hydroxy Acid, Dimethyl Isosorbide, Cetyl Ethylhexanoate, Cetearyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Helianthus Annuus Seed Oil, Isohexadecane, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Glycerin, Polysorbate 80, Cetearyl Glucoside, Hyaluronic Acid, Panthenol, Bisabolol, Trehalose, Opuntia FICUS-INDICA Fruit Extract, Niacinamide, Sorbitan Oleate, Astragalus Membranaceus Root Extract, 1,2-Hexanediol, Caprylyl Hydroxamic Acid, Ethylhexylglycerin, Pentylene Glycol, Centella Asiatica Extract, Saposhnikovia Divaricata Root Extract, Calendula Officinalis Flower Extract, Albizia Julibrissin Julibrissin Flower Extract, Gastrodia Elata Root Extract, Tapioca Starch, Rosemary (ROSMARINUS OFFICINALIS) Leaf Oil


Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS

• Gently cleanse your face with a mild cleanser and pat dry using a clean towel before applying the gel.

• Apply a thin, even layer of the gel directly to the affected areas using clean fingertips, avoiding unbroken or irritated skin.

• Begin with once-daily use, preferably in the evening, and gradually increase to twice daily (morning and evening) as your skin adjusts.

• Allow the gel to fully absorb before applying additional products to ensure optimal effectiveness.

• Discontinue use if irritation, redness, or allergic reaction occurs, and consult a healthcare professional if necessary.

Dosage and Administration (34068-7)

DIRECTIONS

• Gently cleanse your face with a mild cleanser and pat dry using a clean towel before applying the gel.

• Apply a thin, even layer of the gel directly to the affected areas using clean fingertips, avoiding unbroken or irritated skin.

• Begin with once-daily use, preferably in the evening, and gradually increase to twice daily (morning and evening) as your skin adjusts.

• Allow the gel to fully absorb before applying additional products to ensure optimal effectiveness.

• Discontinue use if irritation, redness, or allergic reaction occurs, and consult a healthcare professional if necessary.

Warnings and Precautions (34071-1)

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Section 50565-1 (50565-1)

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Section 50566-9 (50566-9)

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Section 50567-7 (50567-7)

Time of day:

24 HOURS

Routine Order:

Cleanse • Treatment • Moisturize

Section 50570-1 (50570-1)

SAFETY NOTIFICATION

For external use only. Avoid contact with eyes. If accidental contact with eyes occurs, rinse immediately with water. Do not apply to broken or irritated skin. Discontinue use if redness, swelling, or irritation develops, and consult a healthcare professional if necessary. Keep out of reach of children. Store in a cool, dry place away from direct sunlight. If you are pregnant, breastfeeding, or have any skin conditions, consult a dermatologist before use.

Section 51945-4 (51945-4)

label

Section 55105-1 (55105-1)

KEY BENEFITS

• Acne Control & Pore Cleansing:

Salicylic Acid and Beta Hydroxy Acid exfoliate the skin, clear pores, and remove excess oil, effectively reducing and preventing acne.

• Anti-inflammatory & Skin Soothing:

Bisabolol and Centella Asiatica Extract have anti-inflammatory properties to soothe irritation, reduce redness, and calm the skin.

• Hydration & Moisture Retention:

Hyaluronic Acid, Glycerin, and Panthenol attract and retain moisture, providing long-lasting hydration without clogging pores.

• Reduces Hyperpigmentation & Skin Tone Evening:

Niacinamide brightens skin, evens tone, and reduces acne scars and hyperpigmentation.

• Antioxidant Protection & Skin Repair:

Plant extracts like Astragalus Root, Calendula, and Rosemary provide antioxidants, support repair, and enhance skin resilience.

• Strengthens Skin Barrier:

Wheat Germ Ferment Filtrate and Sunflower Seed Oil nourish and strengthen the skin barrier, preventing moisture loss and protecting against irritants.

• Gentle yet Effective:

The formula is gentle while effectively treating acne, balancing oil production without over-drying.

Active Ingredient

Salicylic Acid

Inactive Ingredients

Inactive Ingredients



Water, Butylene Glycol, Triticum Vulgare (Wheat) Germ Ferment Filtrate, Beta Hydroxy Acid, Dimethyl Isosorbide, Cetyl Ethylhexanoate, Cetearyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Helianthus Annuus Seed Oil, Isohexadecane, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Glycerin, Polysorbate 80, Cetearyl Glucoside, Hyaluronic Acid, Panthenol, Bisabolol, Trehalose, Opuntia FICUS-INDICA Fruit Extract, Niacinamide, Sorbitan Oleate, Astragalus Membranaceus Root Extract, 1,2-Hexanediol, Caprylyl Hydroxamic Acid, Ethylhexylglycerin, Pentylene Glycol, Centella Asiatica Extract, Saposhnikovia Divaricata Root Extract, Calendula Officinalis Flower Extract, Albizia Julibrissin Julibrissin Flower Extract, Gastrodia Elata Root Extract, Tapioca Starch, Rosemary (ROSMARINUS OFFICINALIS) Leaf Oil


Advanced Ingredient Data


Raw Label Data

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