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| Product NDC Code | 50594-821 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne scrub |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 562600 | ||||
| Application Number | part333D | ||||
| Labeler Name | Big Lots | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reactions Manufactured for Big Lots by Vi-Jon, In. 8515 Page Avenue St. Louis, MO 63114 V#425040 ITEM #821
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 2%
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 use up to twice daily. Wet face, apply to hands, add water and work into a lather. Massage face gently. Rinse well. avoid contact with the eyes. If contact occurs, flush thoroughly with water.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sodium C14-16 olefin sulfonate, glycerin, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline cellulose, cellulose, carrageenan, C12-15 alkyl lactate, disodium EDTA, cocamidopropyl PG-dimonium chloride phosphate, Citrus grandis (grapefruit) fruit extract, polyquaternium-7, Camellia sinensis leaf extract, ascorbyl palmitate, neopentyl glycol dicaprylate/dicaprate, Anthemis nobilis flower extract, polysorbate 20, polyvinyl alcohol, propylene glycol, benzalkonium chloride, butylene glycol, sodium benzotriazolyl butylphenol sulfonate, agar, mica, titanium dioxide, sodium hydroxide, fragrance, red 30, red 40, ext. violet 2
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 Medication
Spl product data elements
Usually a list of ingredients in a drug product.Acne Scrub Salicylic Acid SALICYLIC ACID SALICYLIC ACID water SODIUM C14-16 OLEFIN SULFONATE GLYCERIN COCAMIDOPROPYL BETAINE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) SODIUM CHLORIDE CELLULOSE, MICROCRYSTALLINE POWDERED CELLULOSE CARRAGEENAN C12-15 ALKYL LACTATE EDETATE DISODIUM COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE GRAPEFRUIT POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) GREEN TEA LEAF ASCORBYL PALMITATE NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE CHAMAEMELUM NOBILE FLOWER POLYSORBATE 20 POLYVINYL ALCOHOL PROPYLENE GLYCOL BENZALKONIUM CHLORIDE BUTYLENE GLYCOL SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE AGAR MICA TITANIUM DIOXIDE sodium hydroxide D&C RED NO. 30 FD&C RED NO. 40 EXT. D&C VIOLET NO. 2
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 SOUND BODY COMPARE TO NEUTROGENA OIL FREE ACNE WASH FOAMING SCRUB OIL Free Acne Scrub PINK GRAPEFUIT SALICYLIC ACID ACNE MEDICATION Helps Fight Breakouts Naturally Derived Grapefruit Extract Non-polyethylene beads gently buff rough skin into a radioant, beautiful complexion. 4.2 FL OZ (124 mL) image description
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.Disclaimer This product is not manufactured or distributed by Neutorgena Corporation, distributor of Oil-Free Acne Wash Pink Grapfruit Foaming Scrub
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? Call 1-888-593-0593
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 is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
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
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