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Acne advanced clarifying hydrator - Medication Information

Product NDC Code 15751-3030
Drug Name

Acne advanced clarifying hydrator

Type Brand
Active Ingredients
Salicylic acid 10 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 417424
Application Number M006
Labeler Name Eminence Organic Skin Care Ltd.
Packages
Package NDC Code Description
15751-3030-2 1 bottle in 1 box (15751-3030-2) / 35 ml in 1 bottle
15751-3030-6 3 ml in 1 packet (15751-3030-6)
15751-3030-9 55 ml in 1 bottle (15751-3030-9)
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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 Cleanse skin thoroughly before applying this product Apply a layer over the entire face and neck 1 to 3 times daily and leave on. Because excessive drying of the skin may occur, start 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 Glycerin], Caprylic/Capric Triglyceride, Hamamelis Virginiana (Witch Hazel), Vegetable Glycerin, Propanediol, Citrus Grandis (Grapefruit) Peel Oil, Mentha Spicata (Spearmint) Leaf Oil, Sodium Acrylate, Nyphaea Caerulea (Blue Lotus) Flower Extract, Nelumbo Nucifera (Sacred Lotus) Flower Extract, Origanum Vulgare (Oregano) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Cinnamomum Zeylanium (Cinnamon) Bark Extract, Olea Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Starch Octenylsuccinate, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Sodium Acrylolydimethyl Taurate Copolymer, Panthenol (Provitamin B5), Sodium Hydroxide, Isohexadecane, Niacinamide (Vitamin B3), Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Polysorbate 80, Lysolecithin, Caffeine (from Green Tea), Zinc Hyaluronate, Arbutin, Cocamidopropyl Dimethylamine, Biocomplex2 [Euterpe Oleracea (Acai), [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) *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 Clarifying Hydrator SALICYLIC ACID ALOE CUCUMBER ROSA MOSCHATA OIL GRAPEFRUIT SYMPHYTUM UPLANDICUM LEAF PEPPERMINT CALENDULA OFFICINALIS FLOWER BETA VULGARIS GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PROPANEDIOL CITRUS MAXIMA FRUIT RIND OIL SPEARMINT SODIUM ACRYLATE OREGANO THYME CINNAMON OLIVE OIL ROSEMARY GOLDENSEAL LEMON DEXPANTHENOL SODIUM HYDROXIDE ISOHEXADECANE NIACIN ALLANTOIN POLYSORBATE 80 LYSOPHOSPHATIDYLCHOLINE, SOYBEAN GREEN TEA LEAF ARBUTIN COCAMIDOPROPYL DIMETHYLAMINE SOYBEAN OIL BENZYL ALCOHOL SUNFLOWER OIL SORBIC ACID SODIUM POLYACRYLATE (2500000 MW) 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.
Acne Advanced Clarifying Hydrator 1.2oz Box (15751-3030-2) Label4 Acne Advanced Clarifying Hydrator 1.2oz Bottle (15751-3030-2) Bottle Acne Advanced Clarifying Hydrator 1.9oz (15751-3030-9) Label5 Acne Advanced Clarifying Hydrator 0.10oz (15751-3030-6) Label00

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 contaact 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 contaact 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