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| Product NDC Code | 65923-493 | ||||
|---|---|---|---|---|---|
| Drug Name | Family care saline |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 707251 | ||||
| Application Number | M012 | ||||
| Labeler Name | United Exchange Corp. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Sodium Chloride 0.65%......................Moisturizer
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.Distributed by: United Exchange Corp. Cypress, CA 90630 USA Made in China
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, benzyl alcohol, purified water, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate
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.Directions holding bottle upright for spray, horizontally for stream, and upside down for drop applications adults and children under 6 years of age: squeeze twice in each nostril as needed children under 6 years of age: consult a doctor using this dispenser by more than one person may spread infection
Purpose
Information about the drug product’s indications for use.Use temporary relief of dry, irritated nasal passages due to colds, flu, allergies, pollution, and the use of decongestants/steroidal sprays
Spl product data elements
Usually a list of ingredients in a drug product.Family Care Saline Sodium Chloride SODIUM CHLORIDE CHLORIDE ION SODIUM PHOSPHATE DIBASIC DIHYDRATE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZYL ALCOHOL WATER BENZALKONIUM CHLORIDE
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.493
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 (1-800-222-1222) right away.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 20-25°C (68-77°F) do not use if printed seal around the cap is broken or missing
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