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| Product NDC Code | 36800-354 | ||||
|---|---|---|---|---|---|
| Drug Name | Body wash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | part333D | ||||
| Labeler Name | TopCo Associates LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid (2.0%)
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 for daily use in shower or bath. Massage over wet skin with a washcloth or body pouf, concentrating on areas prone to breakouts. Rinse well.
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, cocamidopropyl PG-dimonium chloride phosphate, polyquaternium-7, Citrus grandis (grapefruit) fruit extract, Anthemis nobilis flower extract, Camellia sinensis leaf extract, carrageenan, agar, neopentyl glycol dicaprylate/dicaprate, ascorbyl palmitate, propylene glycol, C12-15 alkyl lactate, polysorbate 20, butylene glycol, polyvinyl alcohol, disodium EDTA, sodium chloride, sodium hydroxide, benzalkonium chloride, sodium benzotriazolyl butylphenol sulfonate, fragrance, mica, titanium dioxide, iron oxides, 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.Body Wash Salicylic Acid SALICYLIC ACID SALICYLIC ACID water SODIUM C14-16 OLEFIN SULFONATE GLYCERIN COCAMIDOPROPYL BETAINE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) PUMMELO CHAMAEMELUM NOBILE FLOWER GREEN TEA LEAF CARRAGEENAN AGAR NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE ASCORBYL PALMITATE PROPYLENE GLYCOL C12-15 ALKYL LACTATE POLYSORBATE 20 BUTYLENE GLYCOL POLYVINYL ALCOHOL EDETATE DISODIUM SODIUM CHLORIDE SODIUM HYDROXIDE BENZALKONIUM CHLORIDE SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE MICA TITANIUM DIOXIDE FERRIC OXIDE RED 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 TopCare beauty CLARIFYING BODY WASH Pink Grapefruit Salicylic Acid Acne Treatment Compare to NEUTROGENA Helps fight body breakouts Dermatologist tested with Grapefuit Extract 8.5 FL OZ (251 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.Distributed by Topco Associates LLC, Elk Grove Village, IL 60007 1-888-423-0139 [email protected] www.topcarebrand.com *This product is not manufactured or distributed by the Neutrogena Corporation, distributor of Body Clear Body Wash Pink Graperfuit
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.
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 ame time. If irritation occurs, only use one topical acne medication at a time avoid contact with the eyes. If contact occurs, flush 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
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