SPL v1
SPL
SPL Set ID 37fc7d7f-da18-ac40-e063-6394a90abb5d
Route
TOPICAL
Published
Effective Date 2025-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Aloe Barbadensis Leaf Glycerin Propanediol Butylene Glycol Taraxacum Officinale Glycereth-26 Glyceryl Caprylate Caprylic/capric Triglyceride Water Disodium Edta-copper Polyglyceryl-10 Caprylate Melaleuca Alternifolia Leaf Menthol Glycyrrhiza Glabra (licorice) Rhizome/root Isohexadecane Caprylhydroxamic Acid Borneol O-cymen-5-ol Dimethicone Gentiana Scabra Root Sodium Hyaluronate Scutellaria Baicalensis Root Helichrysum Italicum Flower 1,2-hexanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-20

Description

Salicylic Acid


Medication Information

Warnings and Precautions

For external use only.

Keep out of reach of children.

Do not use on damaged, sunburned, inflamed,or eczema-prone skin or around the eyes.

Pregnant women, breastfeeding mothers and children should use with caution (or follow the doctor's advice).

Indications and Usage

For the treatment of acne.

Dosage and Administration

Use it once or twice a day, and adjustthe frequency according to your ownneeas and circumstances

Description

Salicylic Acid

Section 50565-1

Keep out of reach of children.The above warning information has been listed on the label

Section 50566-9

If there is severe swelling, pain or rash, stop using

immediately and seek medical attention

Section 50570-1

For external use only.Keep out of reach of children.

Do not use on damaged, sunburned, inflamed,or eczema-prone skin or around the eyes.

Pregnant women, breastfeeding mothers and children should use with caution (or follow the

doctor's advice).

Section 51727-6

Water, Aloe Barbadensis Leaf Extract,Glycerin, Propanediol, Caprylic/CapricTriglyceride, lsohexadecane.Polyglycery1-10 Caprylate/Caprate,o-Cymen-5-ol, Dimethicone, ButyleneGlycol, Gentiana Scabra Root ExtractScutellaria Baicalensis Root Extract,Taraxacum Officinale Extract,Helichrysum ltalicum Flower Extract,Licorice Root Extract, 1,2-HexanediolGlycereth-26, Glyceryl Caprylate,Caprylhydroxamic Acid, Menthol,Borneol, Disodium EDTA, MelaleucaAlternifolia Leaf Oil

Section 55105-1

Acne treatment

Reduces blemishes & marks

Minimizes pores & oiliness

Diversified protection

Section 55106-9

Salicylic Acid

Package Label


Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne.

Dosage and Administration (34068-7)

Use it once or twice a day, and adjustthe frequency according to your ownneeas and circumstances

Warnings and Precautions (34071-1)

For external use only.

Keep out of reach of children.

Do not use on damaged, sunburned, inflamed,or eczema-prone skin or around the eyes.

Pregnant women, breastfeeding mothers and children should use with caution (or follow the doctor's advice).

Section 50565-1 (50565-1)

Keep out of reach of children.The above warning information has been listed on the label

Section 50566-9 (50566-9)

If there is severe swelling, pain or rash, stop using

immediately and seek medical attention

Section 50570-1 (50570-1)

For external use only.Keep out of reach of children.

Do not use on damaged, sunburned, inflamed,or eczema-prone skin or around the eyes.

Pregnant women, breastfeeding mothers and children should use with caution (or follow the

doctor's advice).

Section 51727-6 (51727-6)

Water, Aloe Barbadensis Leaf Extract,Glycerin, Propanediol, Caprylic/CapricTriglyceride, lsohexadecane.Polyglycery1-10 Caprylate/Caprate,o-Cymen-5-ol, Dimethicone, ButyleneGlycol, Gentiana Scabra Root ExtractScutellaria Baicalensis Root Extract,Taraxacum Officinale Extract,Helichrysum ltalicum Flower Extract,Licorice Root Extract, 1,2-HexanediolGlycereth-26, Glyceryl Caprylate,Caprylhydroxamic Acid, Menthol,Borneol, Disodium EDTA, MelaleucaAlternifolia Leaf Oil

Section 55105-1 (55105-1)

Acne treatment

Reduces blemishes & marks

Minimizes pores & oiliness

Diversified protection

Section 55106-9 (55106-9)

Salicylic Acid

Package Label (PACKAGE LABEL)


Advanced Ingredient Data


Raw Label Data

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