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Product NDC Code | 78283-005 | ||||
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Drug Name | Babaria oat fresh deodorant and antiperspirant liquid roll-on |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | EMULSION | ||||
Application Number | M019 | ||||
Labeler Name | BERIOSKA SL | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Aluminum chlorohydrate 20% Purpose Antiperspirant
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 to underarms only
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (aqua), steareth-2, glycerin, steareth-21, oat (avena sativa) kernel extract, octenidine HCL, ethylhexylglycerin, propylene glycol, Polysorbate 80, fragrance (parfum), phenoxyethanol, sodium hydroxide, dehydroacetic acid, benzoic acid, sorbic acid, potassium sorbate, sodium benzoate, D&C Yellow No.10 (CI 47005), FD&C Yellow No.5 (CI 19140), FD&C Red No.40 (CI 16035), benzyl alcohol, citronellol, coumarin, eugenol, hexyl cinnamal, linalool, alpha-isomethyl ionone.
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 Reduces underarm sweat 24 hour effective protection
Purpose
Information about the drug product’s indications for use.Purpose Antiperspirant
Spl product data elements
Usually a list of ingredients in a drug product.Babaria Oat Fresh Deodorant and Antiperspirant Liquid Roll-On ALUMINUM CHLOROHYDRATE WATER STEARETH-2 GLYCERIN STEARETH-21 AVENA SATIVA FLOWERING TOP OCTENIDINE HYDROCHLORIDE ETHYLHEXYLGLYCERIN PROPYLENE GLYCOL POLYSORBATE 80 PHENOXYETHANOL SODIUM HYDROXIDE DEHYDROACETIC ACID BENZOIC ACID SORBIC ACID POTASSIUM SORBATE SODIUM BENZOATE D&C YELLOW NO. 10 FD&C YELLOW NO. 5 FD&C RED NO. 40 BENZYL ALCOHOL .BETA.-CITRONELLOL, (R)- COUMARIN EUGENOL .ALPHA.-HEXYLCINNAMALDEHYDE LINALOOL, (+/-)- ISOMETHYL-.ALPHA.-IONONE ALUMINUM CHLOROHYDRATE ALUMINUM CHLOROHYDRATE
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.Package Labeling: Label
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have kidney disease
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on broken skin
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 Posion Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use if rash or irritation occurs
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 Do not use on broken skin Stop use if rash or irritation occurs Ask a doctor before use if you have kidney disease Keep out of reach of children. If swallowed, get medical help or contact a Posion 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