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Product NDC Code | 67879-201 | ||||||||
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Drug Name | Hand therape sanitizer |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | GEL | ||||||||
RxCUI drug identifier | 1654914 | ||||||||
Application Number | M003 | ||||||||
Labeler Name | PHARMAGEL INTERNATIONAL INC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Benzethonium Chloride 0.2%
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 Apply product thoroughly, rubbing hands together briskly until absorbed. Apply as needed. Store at room temperature.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: WATER (AQUA), CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, PEG-100 STEARATE, GLYCERYL STEARATE, CYCLOPENTASILOXANE, STEARIC ACID, GLYCERIN, DIMETHICONE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, PHENOXYETHANOL, TRIETHANOLAMINE, PROPYLENE GLYCOL, CARBOMER, STEARYL ALCOHOL, PEG-7 GLYCERYL COCOATE, CAPRYLYL GLYCOL, POLYSORBATE 40, TOCOPHEROL, ETHYLHEXYLGLYCERIN, SODIUM PCA, BHT, PANTHENOL, HEXYLENE GLYCOL, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, BUTYLENE GLYCOL, RETINYL PALMITATE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, MAGNESIUM ASCORBYL PHOSPHATE, ETHYLHEXYL METHOXYCINNAMATE, UNDECYLENOYL PHENYLALANINE, BUTYL METHOXYDIBENZOYLMETHANE, CAMELLIA SINENSIS(GREEN TEA) LEAF EXTRACT, POLYSORBATE 20, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, FRAGRANCE (PARFUM)
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.USES Hand sanitizer to decrease bacteria on skin. Suitable for repeated use.
Purpose
Information about the drug product’s indications for use.PURPOSE Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.HAND THERAPE SANITIZER BENZETHONIUM CHLORIDE WATER SAFFLOWER OIL PEG-100 STEARATE GLYCERYL MONOSTEARATE CYCLOMETHICONE 5 STEARIC ACID GLYCERIN DIMETHICONE JOJOBA OIL SHEANUT OIL CETYL ALCOHOL PHENOXYETHANOL TROLAMINE PROPYLENE GLYCOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) STEARYL ALCOHOL PEG-7 GLYCERYL COCOATE CAPRYLYL GLYCOL POLYSORBATE 40 TOCOPHEROL ETHYLHEXYLGLYCERIN SODIUM PYRROLIDONE CARBOXYLATE BUTYLATED HYDROXYTOLUENE PANTHENOL HEXYLENE GLYCOL ALOE VERA LEAF BUTYLENE GLYCOL VITAMIN A PALMITATE GLYCYRRHIZA GLABRA MAGNESIUM ASCORBYL PHOSPHATE OCTINOXATE UNDECYLENOYL GLYCINE AVOBENZONE GREEN TEA LEAF POLYSORBATE 20 PALMITOYL TRIPEPTIDE-1 PALMITOYL TETRAPEPTIDE-7 BENZETHONIUM CHLORIDE BENZETHONIUM
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.image description image description image description
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 immediately.
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: • avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water. • if irritation or redness occurs to skin, discontinue use. • if condition continues, consult a physician.
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