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Clean and clear acne spot treatment - Medication Information

Product NDC Code 69968-0804
Drug Name

Clean and clear acne spot treatment

Type Brand
Active Ingredients
Salicylic acid 20 mg/ml
Route TOPICAL
Dosage Form GEL
Application Number M006
Labeler Name Kenvue Brands LLC
Packages
Package NDC Code Description
69968-0804-1 1 tube in 1 carton (69968-0804-1) / 22 ml in 1 tube
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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 • Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily. • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Alcohol Denat., Hamamelis Virginiana(Witch Hazel) Water, Polyacrylamide, Glycerin, C13-14 Isoparaffin, C12-15 Alkyl Lactate, Alcohol, Phenoxyethanol, Cetyl Lactate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Laureth-7, Polysorbate 20, Sodium Hydroxide, Phenethyl Dimethicone, Xanthan Gum, Propylene Glycol, Benzalkonium Chloride, Tetrasodium EDTA

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 treatment 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.
Clean and Clear Acne Spot Treatment Salicylic Acid C12-15 ALKYL LACTATE BENZALKONIUM CHLORIDE EDETATE SODIUM WATER LAURETH-7 SALICYLIC ACID SALICYLIC ACID CETYL LACTATE COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE POLYSORBATE 20 SODIUM HYDROXIDE ALCOHOL HAMAMELIS VIRGINIANA TOP WATER GLYCERIN C13-14 ISOPARAFFIN XANTHAN GUM PROPYLENE GLYCOL PHENOXYETHANOL

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 - 22 mL Tube Carton NEW FORMULA Clean & Clear ® acne spot treatment salicylic acid acne treatment clinically proven results in just 1 day with witch hazel fragrance free OIL FREE 0.75 FL. OZ. (22 mL) Clean and Clear_01

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.
Drug Facts Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call toll-free 1-877-754-6411 or 215-273-8755 (collect). www.cleanandclear.com

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 • Avoid contact with eyes. If contact occurs, immediately flush with water. • 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.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store at room temperature. Sunburn Alert This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

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. Flammable, keep away from open fire or flame. When using this product • Avoid contact with eyes. If contact occurs, immediately flush with water. • 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. 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