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| Product NDC Code | 11822-7701 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 486131 | ||||
| Application Number | M006 | ||||
| Labeler Name | Rite Aid | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction DISTRIBUTED BY: RITE AID 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Benzoyl peroxide 10%
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 daily application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, 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 treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne medication
Spl product data elements
Usually a list of ingredients in a drug product.Acne Treatment Benzoyl peroxide CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE EDETATE DISODIUM HYPROMELLOSES LAURETH-4 SODIUM HYDROXIDE WATER BENZOYL PEROXIDE BENZOYL PEROXIDE
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 MEDICATED ACNE GEL 10% BENZOYL PEROXIDE MAXIMUM STRENGTH** RYSHI ™ COMPARE TO CLEAN & CLEAR ® PERSA-GEL ® 10* NET WT 1 OZ (28 g) image description
Principal display panel daylogic 10% BENZOYL PEROXIDE acne treatment MEDICATED GEL MAXIMUM STRENGTH Maximum Strength Acne Medication Without A Prescription DERMATOLOGIST TESTED Compare to clean & Clear Persa-Gel 10.* NET WT 1 OZ (28 g) image description
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.Side panel claims MEDICATED ACNE GEL 10% BENZOYL PEROXIDE MAXIMUM STRENGTH** **MAXIMUM STRENGTH BENZOYL PEROXIDE ACNE MEDICATION AVAILABLE UNDER THE PRODUCT MONOGRAPH *THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY KENVUE, INC., DISTRIBUTER OF CLEAN & CLEAR ® PERSA-GEL ® 10. TIME TO SHINE GUARANTEE IF YOU ARE NOT SATISFIED, WE WILL HAPPILY REFUND YOUR MONEY.
Claims This micronized benzoyl peroxide formula goes to work releasing the medicine deep into the pore where pimples begin.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you if you have very sensitive skin are sensitive to benzoyl peroxide
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 aother topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time avoid unnecessary sun exposure and use a sunscreen avoid contact with eyes, lips and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, buring, itching, peeling or posible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
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