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Triderma acne spot treatment - Medication Information

Product NDC Code 10738-034
Drug Name

Triderma acne spot treatment

Type Brand
Active Ingredients
Benzoyl peroxide 2.5 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 308688
Application Number part333D
Labeler Name Genuine Virgin Aloe Corporation
Packages
Package NDC Code Description
10738-034-10 1 tube in 1 carton (10738-034-10) / 21 g in 1 tube (10738-034-15)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Benzoyl Peroxide 2.5%

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 the product •cover the entire affected area with a thin layer 1 to 3 times daily •because excessive drying of the skin may occur, start with 1 application daily, then gradually increase 2 to 3 times daily if needed or directed by a doctor •if bothersome dryness or peeling occurs, reduce 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 and ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: water, olive oil glycereth-8 esters, carbomer, aloe barbadensis leaf juice * , sodium hydroxide, phenoxyethanol. * Certified Organic Ingredient - Mayacert Certifier

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 •clears acne blemishes •helps prevent new blemishes from forming.

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.
TRIDERMA Acne Spot Treatment Benzoyl Peroxide WATER OLIVE OIL GLYCERETH-8 ESTERS CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALOE VERA LEAF SODIUM HYDROXIDE PHENOXYETHANOL 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.
packaging untitled

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 For Healthier Looking Skin Clears acne Helps prevent new blemishes from forming Dermatologist Tested • AP4 ® BOTANICAL • ALOE VERA COMPLEX Acne Spot Treatment works quickly to clear acne blemishes and help prevent new blemishes from forming. • Helps keep skin clear • Purifies pores • Pores look smaller Made with acne fighting Benzoyl Peroxide, this powerful serum delivers results for a clear and healthy looking complexion. AP4 ® Botanical Aloe Complex is a proprietary soothing botanical blend • Non-Greasy • No Added Fragrance or Parabens EXPERTS IN SKIN HEALING SINCE 1992 TriDerma MD ® provides healing solutions for irritated skin without harmful side effects. It all began after one woman struggled to find safe and effective healing for her own skin problem. This journey led to the creation of our proprietary AP4 ® Organic Aloe* complex which is key to all our products. QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE ® Each product is made using this powerful complex plus nature's best botanicals and clinically proven ingredients. We are passionate in our pursuit to create fast healing products that work. MADE IN THE USA Maximum Strength Healing Botanicals Dist by: Genuine Virgin Aloe Corp. Corona, CA 92879 ©2019 0819

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? 1-800-279-7282 M-F 8am-4pm PST or www.triderma.com

Storage and handling

Information about safe storage and handling of the drug product.
Other information • store at room temperature • keep carton for important information.

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 • avoid unnecessary sun exposure and use a sunscreen •avoid contact with the eyes, lips and mouth •avoid contact with hair and dyed fabric, which may be bleached by the product •skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if •irritation becomes severe. 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