Salicylic acid

Overview

A compound obtained from the bark of the white willow and wintergreen leaves, and also prepared synthetically. It has bacteriostatic, fungicidal, and keratolytic actions. Its salts, the salicylates, are used as analgesics.

Indication

Key additive in many skin-care products for the treatment of acne, psoriasis, callouses, corns, keratosis pilaris and warts.

Associated Conditions

Acne
Actinic Keratosis (AK)
Alopecia Areata (AA)
Atopic Dermatitis
Blackheads
Chronic Eczema
Contact Dermatitis
Corns
Dandruff
Dermatitis, Eczematous of the scalp
Discoid Lupus Erythematosus (DLE)
Foot Callus
Fungal Infections
Fungal skin infection
Furuncle
Hand Eczema
Hyperkeratosis
Hyperkeratosis follicularis et parafollicularis
Infections, Fungal of the Skin Folds
Infections, Fungal of the face
Infections, Fungal of the feet
Infections, Fungal of the hand
Lichen
Lichen Planopilaris
Lichen Planus (LP)
Lichen simplex chronicus
Lupus Erythematosus, Chronic Cutaneous
Molluscum Contagiosum
Musculoskeletal Pain
Neurodermatitis
Palmoplantar Pustulosis (PPP)
Palmoplantar keratoderma
Plantar Warts
Pruritus
Psoriasis
Psoriasis Vulgaris (Plaque Psoriasis)
Psoriasis of the scalp
Rash
Ringworm of the Skin
Ringworm of the scalp
Seborrheic Dermatitis
Seborrhoea of the scalp
Seborrhoeic Dermatitis of the Scalp
Verruca (Warts)
Verrucous Psoriasis
Bacterial skin infections
Calluses
Corticosteroid-responsive dermatoses
Keratinization disorders
Scaling
Scaling of skin
Superficial Fungal skin infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne	2019/02/06	NCT03832647	Phase 4	Completed	Vichy Laboratoires
Effect of Neem Extract, Propylene Glycol and Salicylic Acid Combination in the Treatment of Arsenical Palmar Keratosis	2015/02/02	NCT02352987	Phase 2	Completed	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts	2014/05/30	NCT02151630	Phase 2	UNKNOWN	Isfahan University of Medical Sciences
Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis	2013/08/02	NCT01914627	Phase 2	Completed	G. Pohl-Boskamp GmbH & Co. KG
A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris	2009/02/18	NCT00845481	Phase 2	Completed	LEO Pharma
Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris	2006/08/08	NCT00361322	Phase 1	Completed	Hadassah Medical Organization

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Psoriasis Scalp Treatment	Rida LLC	83004-026	TOPICAL	3 g in 100 mL	5/28/2025
FAST ACTING WART REMOVER	Shenzhen Yangan Technology Co., Ltd.	84023-115	TOPICAL	1 mg in 100 mL	3/24/2025
El Mata Callos	Vitamex USA, Corp	69469-017	TOPICAL	170 mg in 1 mL	6/23/2025
Keralyt	Summers Laboratories Inc	11086-043	TOPICAL	6 g in 92.6 mL	10/9/2023
Ultrasal-ER	Elorac, Inc.	42783-323	TOPICAL	285 mg in 1 mL	8/8/2016
Dickinsons Original Witch Hazel Clarifying Foam Cleanser	Dickinson Brands Inc.	52651-048	TOPICAL	0.032 g in 1.58 mL	4/10/2025
Foot Scrub	SANSAR, LLC	83691-009	TOPICAL	12 g in 100 g	5/7/2025
QSOOWIS WART CORN REMOVER	Jiangxi Hemei Pharmaceutical Co., Ltd	84010-141	TOPICAL	40 g in 100 1	7/7/2025
Urea 39.5% with 2% Salicylic Acid	PureTek Corporation	59088-210	TOPICAL	2 g in 100 g	3/24/2023
Oil Free Acne Wash	Military Exchanges	55301-947	TOPICAL	20 mg in 1 mL	3/3/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PINEAPPLE BRAND LOTION	BEACONS PHARMACEUTICALS PTE. LTD.	SIN16082P	LOTION	10% w/v	1/19/2021
SAW HONG CHOON SKIN OINTMENT	PRIME PHARMACEUTICAL SDN BHD	SIN09830P	OINTMENT	5% w/w	6/18/1998
CENTA SKIN LOTION 2% w/v	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN04701P	LOTION	2% w/v	6/12/1990
BETACYLIC OINTMENT	Y.S.P. Industries (M) Sdn. Bhd.	SIN15211P	OINTMENT	30mg/g	4/12/2017
SALICYLIC ACID 2% CREAM	ICM PHARMA PTE. LTD.	SIN02882P	CREAM	2% w/w	5/22/1989
NIXODERM OINTMENT	NATURAL WELLNESS INDUSTRIES SDN. BHD.	SIN04418P	OINTMENT	2.50% w/w	5/3/1990
Collomack Salicylic Acid Solution 10%	PAUL W. BEYERS GmbH	SIN13728P	SOLUTION	100mg	11/12/2009
TOH SKIN OINTMENT 5% w/w	ICM PHARMA PTE. LTD.	SIN07382P	OINTMENT	5% w/w	4/5/1993
ICM WHITE SPOT LOTION 5%	ICM PHARMA PTE. LTD.	SIN09177P	LOTION	5% w/v	1/24/1997
COCOIS CO. OINTMENT	ICM PHARMA PTE. LTD.	SIN03627P	OINTMENT	2% w/w	7/24/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
DERMACORN FOOT SOAKING POWDER	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	7/14/2011
RADISOL ACID SALICYLIC APPLICATION	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	1/24/1979
SUSIK POWDER	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	7/3/1998
NIZO SPRAY	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	1/29/2001
CURCYTOL SKIN LOTION (SPRAY)	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/11/1998
WHITASALIC OINTMENT	N/A	MEYER BPC PHARMACEUTICALS LIMITED	N/A	N/A	2/16/1994
DECADOID CORN PLASTER 10%	N/A	ming tai pharmaceuticals company o/b sure brilliant industrial limited	N/A	N/A	8/21/2009
PHENADERM SPRAY	N/A	MEYER BPC PHARMACEUTICALS LIMITED	N/A	N/A	5/27/1988
CORN MATE PLASTER 10%	N/A	ming tai pharmaceuticals company o/b sure brilliant industrial limited	N/A	N/A	3/8/2010
MAGIC POWDER	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	10/14/2007

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SM 33 ADULT FORMULA LIQUID paint bottle	12181	Pharmaco Australia Ltd	Medicine	A	8/9/1991
COCO-SCALP coal tar solution 12% w/w, salicylic acid 2% w/w and sulfur-precipitated 4% w/w ointment tube	206327	AFT Pharmaceuticals Pty Ltd	Medicine	A	2/22/2013
ACTIKERALL fluorouracil and salicylic acid 0.5% / 10% (w/w) topical solution, bottle	287446	Mayne Pharma International Pty Ltd	Medicine	A	8/15/2019
JOHN PLUNKETT'S SUPERFADE SKIN CREAM tube	341504	Sunspot Products Pty Ltd	Medicine	A	8/13/2020
JOHN PLUNKETT'S SUNSPOT CREAM salicylic acid 50 mg/g jar	11630	Sunspot Products Pty Ltd	Medicine	A	9/12/1991
DUOFILM solution bottle	14820	Stada Pharmaceuticals Australia Pty Ltd	Medicine	A	9/12/1991
JOHN PLUNKETT'S PSOR-ASIST CREAM jar	11628	Sunspot Products Pty Ltd	Medicine	A	9/12/1991
SCHOLL WART REMOVAL SYSTEM salicylic acid 400mg/g medicated dressing sachet	53606	Scholls Wellness Company Pty Ltd	Medicine	A	9/29/1995
WART-OFF PAINT bottle	18915	Pharmacare Laboratories Pty Ltd	Medicine	A	9/30/1991
Dr Michaels Scalp & Body Cleansing Gel	281182	Tirsel Pty Ltd	Medicine	A	10/10/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SOLUVER ENFANTS/KIDS	dermtek pharma inc	02245445	Solution - Topical	17 %	7/30/2002
SALICYLIC ACID SOAP 3.5%	stiefel canada ulc	00187542	Soap Bar - Topical	3.5 %	12/31/1966
MEDICATED CALLUS REMOVERS	pittsburgh plastics manufacturing	02248118	Disc - Topical	40 %	12/23/2003
THERAPRO EXFOLIATING DANDRUFF TREATMENT SHAMPOO	canmax laboratories inc.	02237050	Liquid - Topical	1.8 %	N/A
ACNEX LIQ 2%	dermtek pharma inc	00685186	Liquid - Topical	2 %	12/31/1987
CLEARASIL CLEANSER - LIQ 2%	procter & gamble inc	02220741	Liquid - Topical	2 %	7/7/1997
DERMA CONTROLE: GEL NETTOYANT MOUSSANT	yves rocher inc.	02202417	Gel - Topical	.5 %	12/31/1996
ACNE STICK GEL	tp health ltd.	02238787	Gel - Topical	0.5 %	N/A
CLEARASIL STAYCLEAR ZONE CONTROL CLEARSTICK	procter & gamble inc	02238910	Liquid - Topical	2 %	N/A
VITALGINE STAM	produits francais labs inc.	00166308	Liquid - Oral	17.745 MG / 30 G	12/31/1930

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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