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Product NDC Code | 57337-036 | ||||
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Drug Name | Xtracare foaming facial cleanser |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | M016 | ||||
Labeler Name | Rejoice International | ||||
Packages |
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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