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Product NDC Code | 83046-100 | ||||
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Drug Name | Resurfacing acne swipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
Application Number | M006 | ||||
Labeler Name | Oars And Alps LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid 0.5%
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 Cleanse the skin thoroughly before using the product Use the pad to clean and treat the entire affected area one to three times daily Do not rinse Because excessive drying of the skin may occur, start with one application daily, then gradually increase if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce the application Keep jar tightly closed Store at room temperature
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycolic Acid, Sodium Hydroxide, Propanediol, Polysorbate 20, Salix Alba (Willow) Bark Extract, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Cladonia Stellaris Extract (Alpine Caribou Moss), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice, Glycerin, Bisabolol, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Ethylhexylglycerin
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 and blackheads Allows skin to heal Helps prevent new acne pimples from forming
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.Resurfacing acne swipes Salicylic Acid LEVOMENOL DIGLYCERIN ALOE VERA LEAF SALICYLIC ACID SALICYLIC ACID GLYCOLIC ACID SALIX ALBA BARK TETRASODIUM GLUTAMATE DIACETATE WATER HAMAMELIS VIRGINIANA TOP CLADONIA RANGIFERINA WHOLE SODIUM HYDROXIDE PROPANEDIOL POLYSORBATE 20 TEA TREE OIL PHENOXYETHANOL ETHYLHEXYLGLYCERIN Round pads White round pads impregnated with topical acne solution
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 OARS+ALPS ANTI- EVERYTHING PAD With 10% Glycolic Acid ANTI-AGNE +ANTI-AGING + ANTI-POLLUTION + ANTI-INGROWN HAIRS 28 Biodegradable Pads DIRECTIONS: Gently wipe over clean face and neck, avoiding the eye area. Do not rinse. Once absorbed, follow with a gentle moisturizer. Can be used daily. If bothersome dryness or peeling occurs, reduce the application. This formula contains an alpha hydroxy acid (AHA) which can increase skin’s sensitivity to the sun. be sure to apply SPF daily when using this product. CAUTION: For external use only. Avoid Eye area. If product gets in your eyes, rinse thoroughly. Manufactured for Oars + Alps LLC, Chicago, IL 60661 Made in USA 3M 5 PP OARS+ALPS ANTI- EVERYTHING PAD With 10% Glycolic Acid ANTI-AGNE + ANTI-AGING + ANTI-POLLUTION + ANTI-INGROWN HAIRS 28 Biodegradable Pads CRUELTY FREE + GLUTEN FREE + VEGAN FREE OF ALCOHOL, FRAGRANCE PARABENS, PHTHALATES, SULFATES Our pads help clear your complexion and minimize the appearance of pores. This plant based formula contains Glycolic Acid and Salicylic Acid for a gentle chemical exfoliation that help refresh your surface skin cell layer and energize your skin. OARSANDALPS.COM #TAKETOTHEOARS DO NOT FLUSH Manufactured for Oars + Alps LLC Chicago, IL 60661 Made in USA 3M 8 50000 02633 9 LABEL LABEL 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 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 or comments Email us at [email protected], or call (630) 635-7839
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 if you have very sensitive skin or known allergy to aspirin Stop use ask a doctor If excessive itching, dryness, redness, burning or swelling occurs, or if these symptoms persist When using this product • Keep away from eyes, lips and other mucous membranes. If contact occurs, flush thoroughly with water. • Do not leave pad on the skin for an extended period of time. • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by 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