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Phace bioactive clarifying serum - Medication Information

Product NDC Code 65121-683
Drug Name

Phace bioactive clarifying serum

Type Brand
Active Ingredients
Salicylic acid 15 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 248609
Application Number M006
Labeler Name Pure Source, LLC
Packages
Package NDC Code Description
65121-683-01 1 bottle, pump in 1 carton (65121-683-01) / 30 ml in 1 bottle, pump
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Salicylic Acid 1.5% Purpose Acne Treatment

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 after cleansing, apply a thin layer to affected area 1-3 times daily. If irritating dryness or peeling occurs, reduce application to once per day or every other day.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Aqua/Water/Eau, Arnica Montana Flower Extract, Capryloyl Salicylic Acid, Centella Asiatica Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Diisopropyl Adipate, Glycolic Acid, Hydroxyethylcellulose, Hydroxyethylpiperazine Ethane Sulfonic Acid, Methylisothizolinone, Octadedecenedioic Acid, Polysorbate 80, Alcohol Denat., Sodium Hydroxide, Propanediol, Zingiber Officinale (Ginger) 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.
Uses for the treatment of acne reduces the number and severity of acne blemishes and allows skin to heal

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.
PHACE BIOACTIVE CLARIFYING SERUM SALICYLIC ACID WATER ARNICA MONTANA FLOWER CAPRYLOYL SALICYLIC ACID CENTELLA ASIATICA CITRIC ACID MONOHYDRATE CUCUMBER TURMERIC DIISOPROPYL ADIPATE GLYCOLIC ACID HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID METHYLISOTHIAZOLINONE OCTADECENEDIOIC ACID POLYSORBATE 80 SODIUM HYDROXIDE PROPANEDIOL GINGER SALICYLIC ACID SALICYLIC ACID

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.
Package Labeling: ClarifyingSerumLabel

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 Other Information Store in a cool, dark place.

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 immediately.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Toll-free 1-800-942-1498 or visit www.phacebioactive.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 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 eye contact. 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 eye contact. If contact occurs, flush thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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