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| Product NDC Code | 0299-4121 | ||||
|---|---|---|---|---|---|
| Drug Name | Cetaphil acne relief body wash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 562600 | ||||
| Application Number | M006 | ||||
| Labeler Name | Galderma Laboratories, L.P. | ||||
| Packages |
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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. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients BENZYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCAMIDOPROPYL BETAINE, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROGENATED SOYBEAN OIL, HYDROXYPROPYL STARCH PHOSPHATE, LACTIC ACID, LAURIC ACID, PALMITIC ACID, PHENOXYETHANOL, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYDROXIDE, SODIUM LAUROYL GLYCINATE, SODIUM LAUROYL ISETHIONATE, STEARIC ACID, TETRASODIUM EDTA, WATER
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 Acne Relief Body Wash Salicylic Acid Salicylic Acid Salicylic Acid Benzyl Alcohol Shea Butter Cocamidopropyl Betaine Glycerin Soybean Oil Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Hydrogenated Soybean Oil Lactic Acid, Unspecified Form Lauric Acid Palmitic Acid Phenoxyethanol Sodium Benzoate Sodium Chloride Sodium Hydroxide Sodium Lauroyl Glycinate Sodium Lauroyl Isethionate Stearic Acid Edetate Sodium Water Cetaphil Acne Relief BodyWash Front Back Labels
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 - 20 FL OZ bottle #1 Doctor Recommended Sensitive Skincare Brand Cetaphil® ACNE RELIEF BODY WASH Acne-Prone Skin Maximum strength OTC formula to eliminate breakouts 24 hour dryness relief Advanced Moisture Blend 2% Salicylic Acid Acne Treatment 5 skin sensitivity signs 20 FL OZ (591 mL) P55982-1
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. Fort Worth, TX 76177 USA cetaphil.com
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 becomes 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 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.
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
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