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| Product NDC Code | 83834-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Biba acne |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 308689 | ||||
| Application Number | M006 | ||||
| Labeler Name | Esthetic Underground, Inc. | ||||
| 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 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 this product Cover the entire affected area with a thin layer one to three times daily Because excessive dryness of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor If bothersome dryness of peeling occurs, reduce application to once a day every other day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Chlorphenesin, Carbomer, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide, Citric Acid.
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
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.Biba Acne Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE WATER GLYCERIN CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE PENTYLENE GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PROPANEDIOL XANTHAN GUM CAPRYLYL GLYCOL CHLORPHENESIN CITRIC ACID MONOHYDRATE TRISODIUM ETHYLENEDIAMINE DISUCCINATE SODIUM HYDROXIDE ETHYLHEXYLGLYCERIN
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 - 30 mL Bottle Carton BIBA DE SOUSA LOS ANGELES THE ACNE GEL Net wt. 1.02 fl. oz. / 30 mL PRINCIPAL DISPLAY PANEL - 30 mL Bottle 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: www.estheticunderground.com Los Angeles CA 90036
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you have severe acne
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use On sensitive skin If you are allergic to benzoyl peroxide
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, call a poison control center or get medical help 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? 01+ 310-770-5831 [email protected]
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.Stop use and ask a doctor if Irritation becomes severe.
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.When using this product Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time If irritation occurs, use one topical acne medication at a time Avoid contact with eyes, lips & mouth Avoid contact with hair and dyed fabrics, which may be bleached by this 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 Avoid unnecessary sun exposure and use sunscreen.
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 Do not use On sensitive skin If you are allergic to benzoyl peroxide Ask a doctor or pharmacist before use if you have severe acne When using this product Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time If irritation occurs, use one topical acne medication at a time Avoid contact with eyes, lips & mouth Avoid contact with hair and dyed fabrics, which may be bleached by this 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 Avoid unnecessary sun exposure and use sunscreen. Stop use and ask a doctor if Irritation becomes severe. Keep out of reach of children If swallowed, call a poison control center or get medical help 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