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Skin pharmacy advanced acne therapy overnight salicylic acid - Medication Information

Product NDC Code 68634-057
Drug Name

Skin pharmacy advanced acne therapy overnight salicylic acid

Type Brand
Active Ingredients
Salicylic acid 20 g/2ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 103568
Application Number part333D
Labeler Name AMCOL Health & Beauty Solutions, Inc. DBA
Packages
Package NDC Code Description
68634-057-01 1 tube in 1 carton (68634-057-01) / 30 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. Apply a thin layer to affected area once a day before bedtime. If bothersome dryness or peeling occurs, reduce application to 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Ethoxydiglycol, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, PEG-8, Laureth-4, Dimethicone, Aloe Barbadensis Leaf Juice, Polysorbate 80, DEA-Cetyl Phosphate, Polyacrylamide, Propylene Glycol, Sodium Citrate, Bisabolol, C13-14 Isoparaffin, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben Microsponge ® is a registered trademark of AMCOL International Corp. Save carton for complete labeling since all warnings are not included on the inner package. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2014 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in the U.S.A. of U.S. and foreign components V-13649 CVS ® Quality Money Back Guarantee PLEASE RECYCLE V-31490 #987593 FP409 M050790 ________________________________________________________ end of text 160611 AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care 301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com [email protected]

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.
SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID salicylic acid salicylic acid salicylic acid WATER DIETHYLENE GLYCOL MONOETHYL ETHER ETHYLHEXYL PALMITATE CETYL ALCOHOL METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER POLYETHYLENE GLYCOL 400 LAURETH-4 DIMETHICONE ALOE VERA LEAF POLYSORBATE 80 DIETHANOLAMINE CETYL PHOSPHATE POLYACRYLAMIDE (1500 MW) 1,2-PROPANEDIOL, 1-BENZOATE SODIUM CITRATE, UNSPECIFIED FORM LEVOMENOL C13-14 ISOPARAFFIN XANTHAN GUM EDETATE DISODIUM DIAZOLIDINYL UREA METHYLPARABEN PROPYLPARABEN

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 g/2 mL Carton Label SKIN + PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID LOTION with Microsponge * Technology Maximum Strength 2% Salicylic Acid works overnight to help eliminate existing blemishes helps prevent new breakouts from forming contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin fragrance- & oil-free formula exclusively at CVS/pharmacy Actual Size Product on Side Panel 1 FL OZ (30 mL) Principal Display Panel - 20 g/2 mL Carton Label Principal Display Panel - 20 g/2 mL Tube Label SKIN + PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID LOTION with Microsponge * Technology Maximum Strength 2% Salicylic Acid works overnight to help eliminate existing blemishes helps prevent new breakouts from forming contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin fragrance- & oil-free formula exclusively at CVS/pharmacy 1 FL OZ (30 mL) Principal Display Panel - 20 g/2 mL Tube Label

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.
HBS Code (Labeler): FP40901-30.2 Distributor: CVS Pharmacy, Inc. Human OTC Drug Active Ingredients: Salicylic Acid 2% CARTON TEXT ________________________________________________________ SKIN+PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID LOTION with Microsponge® Technology Maximum Strength 2% Salicylic Acid works overnight to help eliminate existing blemishes helps prevent new breakouts from forming contains anti-inflammatory Bisabolol & soothing Ale Vera to calm skin fragrance- & oil-free formula DERMATOLOGIST TESTED exclusively at CVS/pharmacy Actual Size Product on Side Panel 1 FL OZ (30 mL) The advanced Overnight Salicylic Acid Lotion is formulated with Microsponge® technology, which is specially designed to promote healthy, visibly clear skin. This sustained-release acne-fighting technology helps reduce irritation by continuously working overnight, providing efficacy as it gently soothes and moisturizes skin, without clogging pores. Maximum strength salicylic acid exfoliates as it works to help clear existing acne and prevent new breakouts from forming. This unique formula contains anti-inflammatory Bisabolol, and Aloe Vera to help soothe, calm and condition skin. Key Benefits: helps eliminate existing blemishes helps prevent new breakouts from forming soothing, oil-free formula unclogs pores fragrance free Daily Regiment: For best results, use this product with the full Skin+Pharmacy Advanced Acne Therapy regimen. Cleanse Clarifying Daily Cleanser Gentle Exfoliating Scrub Moisturize Active Clearing Lotion Treat Spot Treatment Targeted Treatment Wipes Overnight Salicylic Acid Lotion Mattifying Lotion Warning: This product contains a chemical known to the State of California to cause cancer. Skin+Pharmacy Advanced Acne Therapy is an innovative line of clinically tested skin care products that help reduce the appearance of acne. These products, exclusive to CVS/pharmacy, are less irritating to skin, yet powerful enough to treat breakouts and unclog pores. Let Skin+Pharmacy help improve your appearance toward a clear, acne-free complexion. Actual Size Drug Facts

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. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

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. avoid contact with eyes. If contact occurs, flush 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 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. avoid contact with eyes. If contact occurs, flush thoroughly with water Keep out of reach of children. Do not swallow. 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

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