Acne Care Gel

Acne Care Gel
SPL v2
SPL
SPL Set ID fea499ac-c9b9-4474-e053-6394a90aea03
Route
TOPICAL
Published
Effective Date 2023-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (18 mg)
Inactive Ingredients
Water Glycerin Laureth-7 Ethylhexylglycerin Edetate Disodium Anhydrous Tea Tree Oil Niacinamide Sodium Hydroxide Diethylene Glycol Monoethyl Ether Allantoin Phenoxyethanol Ammonium Acryloyldimethyltaurate/vp Copolymer C13-14 Isoparaffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-30

Description

Gel: Plastic Tube, 25 g

Purpose

Acne care gel

Dosage and Administration

- Cleanse skin thoroughly before applying product. - Dry your face and then apply a thin layer one to three times daily. - Because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily, if needed. - If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Contraindications

Hypersensitivity to any of the components.


Medication Information

Purpose

Acne care gel

Dosage and Administration

- Cleanse skin thoroughly before applying product.

- Dry your face and then apply a thin layer one to three times daily.

- Because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily, if needed.

- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Contraindications

Hypersensitivity to any of the components.

Description

Gel: Plastic Tube, 25 g

Warnings

- For external use only.

- Discontinue if excessive skin irritation develops or increases. If irritation persists, consult with a physician or pharmacist.

- Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.

Properties

A lightweight, water-based alcohol-free gel.

This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that clears out clogged pores, reduces blemishes, and helps to minimize blackheads and breakouts. It dissolves excess sebum, making it suitable for acne-prone skin.

And also, it contains Tea tree oil which has soothing properties and improves the appearance of marks.

In addition to Niacinamide (Vitamin B3) which works best to soothe and lighten skin, visibly minimize pores, and improve uneven skin tone, reduce dark spots and acne spots.

It contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities.

Paraben free, Alcohol free, Fragrance free.

Indications

Helps to clear acne and reduce formation of new blackheads and whiteheads.

Precautions

Keep out of reach of children

Side Effects

Skin irritations, dryness, redness more likely to occur when using another topical acne product at the same time, if irritation occurs, use only one product at a time.

Primary Package

Active Ingredient

Salicylic Acid

Secondary Package

Storage Conditions

Store below 30 C.

Inactive Ingredients

Aqua, Glycerin, Ethoxydiglycol, Polyacrylamide, Ammonium Acryloyldimethyltaurate/VP Copolymer, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), C 13-14 Isoparaffin, Phenoxyethanol, Sodium Hydroxide, Allantoin, Laureth-7, Disodium EDTA, Ethylhexylglycerin.

Form and Presentation

Gel: Plastic Tube, 25 g


Structured Label Content

Purpose

Acne care gel

Warnings

- For external use only.

- Discontinue if excessive skin irritation develops or increases. If irritation persists, consult with a physician or pharmacist.

- Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.

Properties

A lightweight, water-based alcohol-free gel.

This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that clears out clogged pores, reduces blemishes, and helps to minimize blackheads and breakouts. It dissolves excess sebum, making it suitable for acne-prone skin.

And also, it contains Tea tree oil which has soothing properties and improves the appearance of marks.

In addition to Niacinamide (Vitamin B3) which works best to soothe and lighten skin, visibly minimize pores, and improve uneven skin tone, reduce dark spots and acne spots.

It contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities.

Paraben free, Alcohol free, Fragrance free.

Indications

Helps to clear acne and reduce formation of new blackheads and whiteheads.

Precautions

Keep out of reach of children

Side Effects

Skin irritations, dryness, redness more likely to occur when using another topical acne product at the same time, if irritation occurs, use only one product at a time.

Primary Package

Active Ingredient

Salicylic Acid

Contraindications

Hypersensitivity to any of the components.

Secondary Package

Storage Conditions

Store below 30 C.

Inactive Ingredients

Aqua, Glycerin, Ethoxydiglycol, Polyacrylamide, Ammonium Acryloyldimethyltaurate/VP Copolymer, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), C 13-14 Isoparaffin, Phenoxyethanol, Sodium Hydroxide, Allantoin, Laureth-7, Disodium EDTA, Ethylhexylglycerin.

Form and Presentation

Gel: Plastic Tube, 25 g

Dosage and Administration

- Cleanse skin thoroughly before applying product.

- Dry your face and then apply a thin layer one to three times daily.

- Because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily, if needed.

- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.


Advanced Ingredient Data


Raw Label Data

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