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| Product NDC Code | 73581-214 | ||||
|---|---|---|---|---|---|
| Drug Name | Adapalene |
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| Type | Generic | ||||
| Pharm Class | Retinoid [EPC], Retinoids [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 307731 | ||||
| Application Number | ANDA215940 | ||||
| Labeler Name | YYBA CORP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Adapalene USP, 0.1% (retinoid) read consumer information leaflet
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 Adults and children 12 years of age and older: use once daily clean the skin gently and pat dry before applying the product cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, sodium hydroxide.
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 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.Adapalene Adapalene Adapalene Adapalene Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) Edetate Disodium Methylparaben Poloxamer 182 Propylene Glycol Water Sodium Hydroxide
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 - 45 g Tube Carton welmate Compare to the active ingredient in Differin ® Gel † Adapalene Gel USP, 0.1% Acne Treatment ONCE DAILY TOPICAL RETINOID* PREVIOUSLY AVAILABLE ONLY BY PRESCRIPTION DERMATOLOGIST DEVELOPED FDA APPROVED * Read consumer information leaflet before use NET WT 45 g (1.6 oz) PRINCIPAL DISPLAY PANEL - 45 g Tube 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: Wellspring Airmont, NY 10952, U.S.A.
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 damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-923-4914
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 doctor if you become pregnant, or are planning to become pregnant, while using the product you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) irritation becomes severe you see no improvement after 3 months of once daily use
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 limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors do not wax to remove hair in areas where the product has been applied during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe irritation (redness, itching, dryness, burning) is more likely to occur: in the first few weeks of use if using more than one topical acne medication at a time but irritation usually lessens with continued use of this product it may take up to 3 months of once daily use to see results avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. wash hands after use
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. protect from freezing
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 damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product. If pregnant or breast-feeding, ask a doctor before use. When using this product limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors do not wax to remove hair in areas where the product has been applied during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe irritation (redness, itching, dryness, burning) is more likely to occur: in the first few weeks of use if using more than one topical acne medication at a time but irritation usually lessens with continued use of this product it may take up to 3 months of once daily use to see results avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. wash hands after use Stop use and ask doctor if you become pregnant, or are planning to become pregnant, while using the product you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) irritation becomes severe you see no improvement after 3 months of once daily use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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