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| Product NDC Code | 49283-707 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Footspa pedi |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| RxCUI drug identifier | 1041849 | ||||||||
| Application Number | part333A | ||||||||
| Labeler Name | CHEMCO CORPORATION | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Ethyl Alcohol 70%v/v
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: Adults and children 12 years of age or older • Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water (Aqua), Camphor, Polysorbate 20, Menthol, DMDM Hydantoin, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, D&C Yellow No.11(CI 47000), FD&C Blue No.1 (CI 42090).
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: To decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.FOOTSPA PEDI ALCOHOL WATER POLYSORBATE 20 MENTHOL FD&C BLUE NO. 1 CAMPHOR (SYNTHETIC) ALCOHOL ALCOHOL PEPPERMINT OIL EUCALYPTUS OIL D&C YELLOW NO. 11 DMDM HYDANTOIN
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.FOOTSPA - ANTIBACTERIAL PEDI SPRAY 4 oz PEDI SPRAY 4
FOOTSPA - ANTIBACTERIAL PEDI SPRAY 16 oz PEDI SPRAY 16
FOOTSPA - ANTIBACTERIAL PEDI SPRAY 128 oz PEDI SPRAY 1
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 If you have redness over affected area.
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.If swallowed, get medical help, or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.FLAMMABLE: Keep away from fire or flame.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Contact us +1 (305) 623-4445
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.Condition persists for more than 72 hours.
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.• For external use only. • Avoid contact with eyes or mucous membrane. • Do not apply to wounds or damaged skin with a heating pad or on a child under 12 year of age.
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