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| Product NDC Code | 53499-5190 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Califlora |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| Labeler Name | Schwabe North America, Inc | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Califlora
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose If swallowed, seek meidcal help or contact a Poison Control Center immediately.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Contains 10% CALENDULA OFFICINALIS 1X
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.Dosage & Administration Apply think layer to affected area. For best results, use promptly after injury or trauma occurs. For minor burns, first run cool water on the burn area and dry. For minor skin irritation, first wash the area with mild soap, rinse and dry. Adults and children 2 years of age and older: Apply to affected area. Repeat as necessary. Children under 2 years of age: Consult a doctor Patch test recommended on sensitive skin.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient CARBOMER ETHYL ALCOHOL PURIFIED WATER SODIUM HYDROXIDE WITCH HAZEL DISTILLATE
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.Indications and Use Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin. Helps promote healing of minor burns and skin irritations.
Purpose
Information about the drug product’s indications for use.Purpose Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin. Helps promote healing of minor burns and skin irritations.
Spl product data elements
Usually a list of ingredients in a drug product.Califlora Calendula officinalis CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP CARBOMER HOMOPOLYMER TYPE C ALCOHOL WATER SODIUM HYDROXIDE WITCH HAZEL
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.LBN21825197.A01 Z Califlora Gel 2.75 oz.jpg
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 doctor Ask a doctor before use in case of deep cuts or puncture wounds, animal bites or serious burns.
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 Do not use on broken skin. Do not use if hypersensitive to any ingredients in this product. Breast-feeding women shoud ot apply to breast 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.Keep out of reach children Keep out of reach of children.
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy or breast feeding If pregnant or breast-feeding, ask a healthcare professional before use.
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.Warning For external use only. Avoid contact with eyes.
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