Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 9add83f2-7da6-4cd0-b91b-f6c937a56255
Route
TOPICAL
Published
Effective Date 2023-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Distearyl Phthalamic Acid Sodium Methyl Cocoyl Taurate Sodium Chloride Cetyl Alcohol Stearyl Alcohol Peg-120 Methyl Glucose Dioleate Phenoxyethanol Sodium Hydroxide Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Edetate Disodium Isopropyl Alcohol Aloe Vera Leaf Butylene Glycol Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Salicylic Acid 2%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2%

Use

For the management of acne

Section 42229-5

Distributed by:

Galderma Laboratories, L.P.          

Dallas, TX 75201 USA



All trademarks are the property

of their respective owners.



cetaphil.com

P56651-2

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation become severe

Section 50567-7

When using this product

  • 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 topical acne treatment at a time.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Warnings

For external use only

Directions

Apply to dampened skin and gently massage, avoiding the eye area. Rinse thoroughly and pat dry. Designed for twice daily use. Can be used less frequently if dryness occurs.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Sodium Methyl Cocoyl Taurate, Sodium Chloride, Cetyl Alcohol, Stearyl Alcohol, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Butylene Glycol, Camellia Sinensis Leaf Extract

Principal Display Panel 4.2 Fl Oz Tube



NEW LOOK

Cetaphil          

Gentle Clear

Clarifying

Acne Cream

Cleanser

2% Salicylic Acid

      Acne Treatment

Deep cleans and exfoliates

to unclog pores preventing

future breakouts

Salicylic Acid, White Tea

& Aloe

Dermatologist Recommended

Sensitive Skin logo



4. 2 FL OZ (124 mL)


Structured Label Content

Use

For the management of acne

Section 42229-5 (42229-5)

Distributed by:

Galderma Laboratories, L.P.          

Dallas, TX 75201 USA



All trademarks are the property

of their respective owners.



cetaphil.com

P56651-2

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation become severe

Section 50567-7 (50567-7)

When using this product

  • 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 topical acne treatment at a time.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Purpose

Acne Treatment

Warnings

For external use only

Directions

Apply to dampened skin and gently massage, avoiding the eye area. Rinse thoroughly and pat dry. Designed for twice daily use. Can be used less frequently if dryness occurs.

Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Sodium Methyl Cocoyl Taurate, Sodium Chloride, Cetyl Alcohol, Stearyl Alcohol, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Butylene Glycol, Camellia Sinensis Leaf Extract

Principal Display Panel 4.2 Fl Oz Tube (PRINCIPAL DISPLAY PANEL - 4.2 FL OZ tube)



NEW LOOK

Cetaphil          

Gentle Clear

Clarifying

Acne Cream

Cleanser

2% Salicylic Acid

      Acne Treatment

Deep cleans and exfoliates

to unclog pores preventing

future breakouts

Salicylic Acid, White Tea

& Aloe

Dermatologist Recommended

Sensitive Skin logo



4. 2 FL OZ (124 mL)


Advanced Ingredient Data


Raw Label Data

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