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| Product NDC Code | 57337-032 | ||||
|---|---|---|---|---|---|
| Drug Name | Oil-free foaming acne wash tea tree oil |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 562600 | ||||
| Application Number | part333D | ||||
| Labeler Name | Rejoice International | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Salicylic Acid 2.0% ................. 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 Wet face. Dispense into palm, apply to face and massage gently. Rinse thoroughly and pat dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline wax, DMDM hydantoin, fragrance, disodium EDTA, sodium lauryl sulfate, sodium hydroxide, propylene glycol, melaleuca altemifolia (tea tree) leaf oil, fd&c blue no.1, fd&c yellow no.5.
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.This XtraCare foaming acne facial scrub gently cleanses breakouts you already have and helps prevent them from returning. It works deep to clean and soothe without overdrying or irritating skin. Rinses clean, leaving no residue to clog pores. Uses For acne-prone skin.
Purpose
Information about the drug product’s indications for use.XtraCare Oil-Free Foaming Acne Wash Facial Scrub WITH TEA TREE OIL helps clear breakouts Salicylic Acid 2% Net Wt 5.3 Oz (150g)
Spl product data elements
Usually a list of ingredients in a drug product.Oil-Free Foaming Acne Wash Tea Tree Oil Salicylic Acid PROPYLENE GLYCOL BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) SODIUM CHLORIDE MICROCRYSTALLINE WAX DMDM HYDANTOIN WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM LAURYL SULFATE EDETATE DISODIUM SODIUM HYDROXIDE MELALEUCA ALTERNIFOLIA LEAF FD&C BLUE NO. 1 FD&C YELLOW NO. 5 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.Label
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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at 20o to 25oC (68o to 77oF) DISTRIBUTED BY REJOICE INTERNATIONAL INC 48325 BINGHAMPTON DR 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 and other topical acne medications at the same time or immediately following use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.
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