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Product NDC Code | 57468-708 | ||||
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Drug Name | Pearlescent |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOAP | ||||
RxCUI drug identifier | 1362618 | ||||
Application Number | part333A | ||||
Labeler Name | Boelter Companies Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Pearlescent Active Ingredient Chloroxylenol 0.375%
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.Pearlescent Directions Read the entire label before using this product. Dispense 1-2 pumps of product onto wet palm. Lather and rinse hands with clean water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Pearlescent Inactive Ingredients Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.
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.Pearlescent Uses Antibacterial hand cleaner. Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
Purpose
Information about the drug product’s indications for use.Pearlescent Purpose Antibacterial
Spl product data elements
Usually a list of ingredients in a drug product.Pearlescent Chloroxylenol WATER COCO DIETHANOLAMIDE COCAMIDOPROPYL BETAINE PHENOXYETHANOL PROPYLENE GLYCOL MYRCENE LAURIC DIETHANOLAMIDE TRIBASIC CALCIUM PHOSPHATE D&C GREEN NO. 5 FD&C YELLOW NO. 5 CHLOROXYLENOL CHLOROXYLENOL CALCIUM SILICATE CALCIUM CATION SODIUM LAURYL SULFATE DIMETHYL BENZYL CARBINYL BUTYRATE BENZYL BENZOATE DIOXANE SODIUM HYDROXIDE METHYLISOTHIAZOLINONE METHYL ALCOHOL .GAMMA.-DECALACTONE MAGNESIUM NITRATE SODIUM ALUMINIUM SILICATE SODIUM FERROCYANIDE ETHYL ACETOACETATE LAURIC ISOPROPANOLAMIDE DIMETHYL BENZYL CARBINYL ACETATE SODIUM CARBONATE GLYCOL DISTEARATE METHYL ANTHRANILATE METHYLCHLOROISOTHIAZOLINONE ETHYL METHYLPHENYLGLYCIDATE ETHYL BUTYRATE ETHYLENE OXIDE CHLOROACETIC ACID LINALOOL, (+/-)-
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.Pearlescent Boelter - 141
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.Pearlescent KEEP OUT OF REACH OF CHILDREN
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.Pearlescent Warnings For external use only. Avoid contact with eyes. Children under the age of 6 should be supervised by an adult when using this product. Discontinue use is irritation or redness develops. If irritation persists for more than 72 hours, consult a physician. KEEP OUT OF REACH OF CHILDREN .
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