SPL v2
SPL
SPL Set ID 1f3d93f0-3a53-d6f0-e063-6394a90a2aff
Route
TOPICAL
Published
Effective Date 2022-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Ethylhexyl Palmitate Silica Dimethyl Silylate Phenoxyethanol Squalane Caprylyl Glycol Polyacrylamide (10000 Mw) Water Sucrose C13-14 Isoparaffin Glycerin Sodium Cocoyl Isethionate Laureth-7

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-06

Description

Salicylic Acid 2.0%


Medication Information

Warnings and Precautions
  • For external use only.
Indications and Usage
  • For the treatment of acne.
Dosage and Administration
  • Lather a quarter-sized amount in hands & gently massage onto damp skin. Rinse throughly with warm water. For best results, follow with ACNE RELIEF Calming Treatment & Hydrator in the morning & ACNE RELIEF Retinol Treatment & Moisturizer in the evening.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Sensitivity Test for a New User Apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs, follow the directions stated above.
Description

Salicylic Acid 2.0%

Section 50565-1
  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50567-7
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one tropical acne medication at a time.
Section 51727-6

Glycerin, Sodium Cocoyl Isethionate, Ethylhexyl Palmitate, Silica Cetyl Silylate, Sucrose, Phenoxyethanol, Polyacrylamide, Water/Aqua/Eau, Caprylyl Glycol, C13-14 Isoparaffin, Squalane, Laureth-7

Section 51945-4

Section 53413-1
  • 1-888-823-7837
Section 55105-1
  • Acne Treatment
Section 55106-9
  • Salicylic Acid 2.0%

Structured Label Content

Indications and Usage (34067-9)
  • For the treatment of acne.
Dosage and Administration (34068-7)
  • Lather a quarter-sized amount in hands & gently massage onto damp skin. Rinse throughly with warm water. For best results, follow with ACNE RELIEF Calming Treatment & Hydrator in the morning & ACNE RELIEF Retinol Treatment & Moisturizer in the evening.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Sensitivity Test for a New User Apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs, follow the directions stated above.
Warnings and Precautions (34071-1)
  • For external use only.
Section 50565-1 (50565-1)
  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50567-7 (50567-7)
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one tropical acne medication at a time.
Section 51727-6 (51727-6)

Glycerin, Sodium Cocoyl Isethionate, Ethylhexyl Palmitate, Silica Cetyl Silylate, Sucrose, Phenoxyethanol, Polyacrylamide, Water/Aqua/Eau, Caprylyl Glycol, C13-14 Isoparaffin, Squalane, Laureth-7

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
  • 1-888-823-7837
Section 55105-1 (55105-1)
  • Acne Treatment
Section 55106-9 (55106-9)
  • Salicylic Acid 2.0%

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)