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Cetaphil gentle clear clarifying acne cleanser - Medication Information

Product NDC Code 0299-4119
Drug Name

Cetaphil gentle clear clarifying acne cleanser

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 562600
Application Number M006
Labeler Name Galderma Laboratories, L.P.
Packages
Package NDC Code Description
0299-4119-00 124 ml in 1 tube (0299-4119-00)
0299-4119-05 5 ml in 1 tube (0299-4119-05)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Salicylic Acid 2%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use For the management of acne

Purpose

Information about the drug product’s indications for use.
Purpose Acne Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Cetaphil Gentle Clear Clarifying Acne Cleanser Salicylic Acid Salicylic Acid Salicylic Acid 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 P56651-2 tube

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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)

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Distributed by: Galderma Laboratories, L.P. Dallas, TX 75201 USA All trademarks are the property of their respective owners. cetaphil.com P56651-2

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if irritation become severe

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only 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. Stop use and ask a doctor if irritation become severe Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API