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Acne advanced cleansing - Medication Information

Product NDC Code 15751-3010
Drug Name

Acne advanced cleansing

Type Brand
Active Ingredients
Salicylic acid 10 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1038982
Application Number part333D
Labeler Name Eminence Organic Skin Care Ltd.
Packages
Package NDC Code Description
15751-3010-5 1 bottle in 1 box (15751-3010-5) / 150 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic Acid 1% 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.
Direcitons Use 1 to 3 times daily. Pump a small amount of product to transform the liquid into a lightweight foam. Apply to skin and massage gently with fingertips in a circular motion covering the face and neck. Rinse thoroughly and pat dry. Because excessive drying of the skin may occur, strar with one application daily, then gradually increase to 2 ot 3 times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) Peel Extract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glyceri], Decyl Glucoside, Sodium Cocoyl Glutamate, Citrus Grandis (Grapefruit) Peel Oil, Metha Spicata (Spearmint) Leaf Oil, Caprylyl Glycol, Tocopherol (Vitamin E), Panthenol (Provitamin B5), Thymus Vulgans (Thyme) Extract, Cinnamomum Zeylanicum (Cinnamon) Bark Extract, Ole Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Cocamidopropyl Dimethylamine, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Ethylhexylglycerin, Caffeine (from Green Tea), Sodium PCA, Arbutin, Biocomplex2 [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10), Vegetable Glycerin. *Certified organic ingredient

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.
Acne Advanced Cleansing SALICYLIC ACID ALOE CUCUMBER ROSA MOSCHATA OIL GRAPEFRUIT SYMPHYTUM UPLANDICUM LEAF PEPPERMINT CALENDULA OFFICINALIS FLOWER BETA VULGARIS GLYCERIN DECYL GLUCOSIDE SODIUM COCOYL GLUTAMATE SPEARMINT CAPRYLYL GLYCOL TOCOPHEROL DEXPANTHENOL THYME CINNAMON OLIVE OIL ROSEMARY COCAMIDOPROPYL DIMETHYLAMINE GOLDENSEAL LEMON ETHYLHEXYLGLYCERIN GREEN TEA LEAF SODIUM PYRROLIDONE CARBOXYLATE ARBUTIN ACAI CARROT COCONUT STARCH, TAPIOCA THIOCTIC ACID UBIDECARENONE SALICYLIC ACID SALICYLIC ACID

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.
Package Labeling for Box: Label Package Labeling for Bottle: Bottle

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 Other information Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

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.

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 when using another topical acne product at the same time. If irritation occurs, use only one product at a time. Avoid eye area. In case of eye contact, flush gently and thoroughly with water.

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 Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, use only one product at a time. Avoid eye area. In case of eye contact, flush gently and thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact 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