SPL v2
SPL
SPL Set ID 9845c715-9409-42d3-b542-951c5e60962d
Route
TOPICAL
Published
Effective Date 2023-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Diethylene Glycol Monoethyl Ether Mandelic Acid Butylene Glycol Lactic Acid, Unspecified Form Niacinamide Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Sodium Acrylates Crosspolymer-2 Sodium Pyrrolidone Carboxylate Hyaluronate Sodium Glycerin Zinc Pidolate Gluconolactone Maltodextrin Polysorbate 20 Lecithin, Soybean Syringa Vulgaris Pollen Milk Thistle Green Tea Leaf White Tea Aspalathus Linearis Leaf Glycyrrhiza Glabra Centella Asiatica Triterpenoids Asian Ginseng Salix Alba Bark Arctium Lappa Root Azadirachta Indica Leaf Sunflower Oil Glycyrrhizinate Dipotassium Panthenol Allantoin Tocopherol Sodium Hydroxide Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Phenoxyethanol Sodium Benzoate Potassium Sorbate Sorbitan Isostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-04-06

Description

Salicylic acid  0.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid  0.5%

Uses

For the treatment of acne.

Warnings

For external use only.

When using this product : skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If

irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask doctor if skin irritation occurs.

Keep out of reach of children. If product is swallowed get medical help or contact a poison control center right away.

Direction

After cleansing, apply one to two pumps on dry skin. Cover your entire face, not just the visible acne, and avoid the eye area. Let it dry before applying other products. Because irritation or excessive drying of the skin may occur, start with one application every other day, and work up to using daily. Follow with SPF when using in the morning. Reduce application if irritation occurs.

Product Label

Active Ingredient

Salicylic acid  0.5%

Other Information

Made in USA 

Distributed by Parea, Inc.

New York, NY 10013 USA

becoolasacucumber.com 

Inactive Ingredients

water, diethylene glycol monoethyl ether, mandelic acid, butylene glycol, lactic acid, unspecified form, niacinamide, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer(100000 mpa.s at 1.5%), sodium acrylates crosspolymer-2, sodium pyrrolidone carboxylate, hyaluronate sodium, glycerin, zinc pidolate, gluconolactone, maltodextrin, polysorbate 20, lecithin, soybean, syringa vulgaris pollen, milk thistle, green tea leaf, white tea, aspalathus linearis leaf, glycyrrhiza glabra, centella asiatica triterpenoids, asian ginseng, salix alba bark, arctium lappa root, azadirachta indica leaf, sunflower oil, glycyrrhizinate dipotassium, panthenol, allantoin, tocopherol, sodium hydroxide, caprylyl glycol, ethylhexylglycerin, hexylene glycol, phenoxyethanol, sodium benzoate, potassium sorbate, sorbitan isostearateonic


Structured Label Content

Uses

For the treatment of acne.

Purpose

Acne treatment

Warnings

For external use only.

When using this product : skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If

irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask doctor if skin irritation occurs.

Keep out of reach of children. If product is swallowed get medical help or contact a poison control center right away.

Direction

After cleansing, apply one to two pumps on dry skin. Cover your entire face, not just the visible acne, and avoid the eye area. Let it dry before applying other products. Because irritation or excessive drying of the skin may occur, start with one application every other day, and work up to using daily. Follow with SPF when using in the morning. Reduce application if irritation occurs.

Product Label (Product label)

Active Ingredient (Active ingredient)

Salicylic acid  0.5%

Other Information (Other information)

Made in USA 

Distributed by Parea, Inc.

New York, NY 10013 USA

becoolasacucumber.com 

Inactive Ingredients (Inactive ingredients)

water, diethylene glycol monoethyl ether, mandelic acid, butylene glycol, lactic acid, unspecified form, niacinamide, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer(100000 mpa.s at 1.5%), sodium acrylates crosspolymer-2, sodium pyrrolidone carboxylate, hyaluronate sodium, glycerin, zinc pidolate, gluconolactone, maltodextrin, polysorbate 20, lecithin, soybean, syringa vulgaris pollen, milk thistle, green tea leaf, white tea, aspalathus linearis leaf, glycyrrhiza glabra, centella asiatica triterpenoids, asian ginseng, salix alba bark, arctium lappa root, azadirachta indica leaf, sunflower oil, glycyrrhizinate dipotassium, panthenol, allantoin, tocopherol, sodium hydroxide, caprylyl glycol, ethylhexylglycerin, hexylene glycol, phenoxyethanol, sodium benzoate, potassium sorbate, sorbitan isostearateonic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)