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| Product NDC Code | 71714-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Tiege hanley daily moisturizing acne |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2632542 | ||||
| Application Number | part333D | ||||
| Labeler Name | TIEGE HANLEY,Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Salicylic Acid 1.6%
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 face thoroughly with Tiege Hanley WASH before applying this product Dispense approximately 3 pumps–enough to cover the entire affected area with a thin layer, including the face and neck For best results, use before bedtime For severe acne, add morning application after WASH, only if followed by AM moisturizer with SPF 20 Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once per day or every other day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua, Glycerin, Cyclopentasiloxane, Cocamidopropyl Dimethylamine, Ethyl Palmate, Behenyl Alcohol, Zea Mays (Corn) Starch, Beheneth-5, Polyglyceryl-3 Stearate, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ceteareth-25, Medicago Sativa (Alfalfa) Extract, Plantago Major Leaf Extract, Calendula Officinalis Flower Extract, Aleurites Moluccanus Seed Oil, Xanthan Gum, Sodium Hyaluronate
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 management 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.Tiege Hanley Daily Moisturizing Acne SALICYLIC ACID SALICYLIC ACID SALICYLIC ACID WATER STARCH, CORN XANTHAN GUM GLYCERIN POLYGLYCERYL-3 STEARATE BEHENETH-5 GLYCERYL MONOSTEARATE PEG-100 STEARATE CETEARETH-25 ETHYL PALMATE DOCOSANOL CYCLOMETHICONE 5 ALFALFA TOP PLANTAGO MAJOR LEAF CALENDULA OFFICINALIS FLOWER HYALURONATE SODIUM PHENOXYETHANOL CAPRYLYL GLYCOL KUKUI NUT OIL COCAMIDOPROPYL DIMETHYLAMINE off white
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 - 24 g Bottle Label TIÉGE HANLEY Uncomplicated Skin Care for Men ® ACNE Daily Moisturizing Acne Cream Net Wt 0.85 oz (24 g) Principal Display Panel - 24 g Bottle Label
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 Tiege Hanley, Inc. Chicago, IL 60612
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 if you have very sensitive skin are sensitive to salicylic acid
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
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 do not use this product more than twice per day discontinue use if skin irritation occurs avoid contact with eyes if going outside, apply sunscreen after using this product skin irritation and dryness are more likely to occur if you use more than one acne medication at the same time if irritations occur only use one topical acne medication at a time avoid aggressive soaps if irritations are experienced
Storage and handling
Information about safe storage and handling of the drug product.Other Information When not using, keep at room temperature with the cap closed
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 do not use this product more than twice per day discontinue use if skin irritation occurs avoid contact with eyes if going outside, apply sunscreen after using this product skin irritation and dryness are more likely to occur if you use more than one acne medication at the same time if irritations occur only use one topical acne medication at a time avoid aggressive soaps if irritations are experienced Do not use if you have very sensitive skin are sensitive to salicylic acid Stop use and ask a doctor if irritation becomes severe 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