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| Product NDC Code | 50066-802 | ||||
|---|---|---|---|---|---|
| Drug Name | Asepxia neutral acne bar |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOAP | ||||
| RxCUI drug identifier | 312882 | ||||
| Application Number | M006 | ||||
| Labeler Name | Genomma Lab USA | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid, 2% Purpose 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 Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne. Rinse thoroughly and pat dry with a clean towel. If bothersome dryness or peeling occurs, reduce application to every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sodium palmate, Sodium cocoate and/or Sodium palm kernelate, Water, Glycerin, Sodium laureth sulfate, Sodium hydroxide, Sodium chloride, Titanium dioxide, Glycereth-26, Tetrasodium EDTA, Glycolic acid, Mineral oil, Prunus persica (Peach) fruit extract, Stearic Acid, Glyceryl stearate, Cetyl alcohol, Salix alba (White Willow) bark extract, Disodium EDTA, Citric acid, Triethanolamine, Opuntia Ficus-Indica (Cactus) stem extract, Carbomer, Pentasodium pentetate
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 Reduces the number of acne pimples Allows skin to heal Penetrates pores to clear most acne blemishes Dries up acne pimples Helps keep skin clear of new acne blemishes, acne pimples, whiteheads and blackheads
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.Asepxia Neutral Acne Bar SALICYLIC ACID SODIUM PALMATE SODIUM COCOATE SODIUM PALM KERNELATE WATER GLYCERIN SODIUM LAURETH-3 SULFATE SODIUM HYDROXIDE SODIUM CHLORIDE TITANIUM DIOXIDE GLYCERETH-26 EDETATE SODIUM GLYCOLIC ACID MINERAL OIL PEACH STEARIC ACID GLYCERYL MONOSTEARATE CETYL ALCOHOL EDETATE DISODIUM ANHYDROUS CITRIC ACID MONOHYDRATE TROLAMINE OPUNTIA FICUS-INDICA STEM CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PENTASODIUM PENTETATE SALICYLIC ACID SALICYLIC ACID Asepxia
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 - 113 g Bar Carton NEW FORMULA SENSITIVE SKIN WITH IMPERFECTIONS ™ Acne Bar Soap Asepxia ® WITH HYDRO-FORCE DEEP CLEANSING GENTLE CARE Neutral 2% Salicylic Acid > Hypoallergenic > Fights imperfections Net Wt. 4 oz (113 g) PRINCIPAL DISPLAY PANEL - 113 g Bar Carton
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
Distributed by: Genomma Lab USA Inc., Houston, TX 77027
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.. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.For more product information, please call Toll Free: 1 877 99 GENOM (43666)
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.excessive skin irritation occurs Stop use and ask a doctor if
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., skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor. Avoid contact with eyes. If product gets in eyes, rinse with water. When using this product
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature
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 , skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor. Avoid contact with eyes. If product gets in eyes, rinse with water. When using this product excessive skin irritation occurs Stop use and ask a doctor if . If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children
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