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Xtracare foaming facial cleanser - Medication Information

Product NDC Code 57337-036
Drug Name

Xtracare foaming facial cleanser

Type Brand
Active Ingredients
Triclosan 1 mg/237mg
Route TOPICAL
Dosage Form GEL
Application Number M016
Labeler Name Rejoice International
Packages
Package NDC Code Description
57337-036-01 237 mg in 1 bottle (57337-036-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Purpose Triclosan 0.25% ........................... Antiseptic

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 mix in hands with water. Work into a foamy later. Smooth over face and neck. Rinse thoroughly.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients water, sodium c14-16 olefin sulfonate, cocamide betaine, glycerin, PEG-40 hydrogenated castor oil, fragrance, DMDM hydantoin, disodium EDTA, citric acid, methylparaben, propylparaben, fd&c yellow no.5, d&c red no.33

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 to help reduce bacteria on the skin

Purpose

Information about the drug product’s indications for use.
XtraCare (oil-free) foaming facial cleanser medicated to kill problem-causing bacteria without overdrying Compare to Clean & Clear® Foaming Facial Cleanser 8 fl. oz. (237 mL) oil free foaming facial cleanser

Spl product data elements

Usually a list of ingredients in a drug product.
XtraCare Foaming Facial Cleanser Triclosan WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE POLYOXYL 40 CASTOR OIL DMDM HYDANTOIN EDETATE DISODIUM CITRIC ACID MONOHYDRATE METHYLPARABEN PROPYLPARABEN FD&C YELLOW NO. 5 D&C RED NO. 33 TRICLOSAN TRICLOSAN

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.
label image

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Do not store where water may enter bottle. *This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®foaming facial cleanser. DISTRIBUTED BY: REJOICE INTERNATIONAL INC. NORTHVILLE, MI 48168 USA MADE IN CHINA

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 contact with eyes. if eye contact occurs, immediately flush with water. Stop use and ask a doctor if excessive skin irritation develops or condition worsens symptoms last more than 7 days or clear up and occur again within a few days

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