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Product NDC Code | 62106-1177 | ||||
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Drug Name | Calendula cream |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Labeler Name | Seroyal USA | ||||
Packages |
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Overdosage of Calendula Cream
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.If swallowed, get medical help or contact a Poison Control Center right away.
If swallowed, get medical help or contact a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Calendula officinalis (Marigold) Aerial Parts MT 5.0%
Active ingredients This preparation contains: Arnica montana (Mountain arnica) Aerial Parts MT 5.0% Calendula officinalis (Marigold) Aerial Parts MT 2.0%
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: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. Children: Use under the direction of your healthcare practitioner.
Directions Adults: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. Children: Use under the direction of your healthcare practitioner.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Cetostearyl alcohol, glycerin, purified water, rose oil
Inactive ingredients Cetostearyl alcohol, glycerin, purified water
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 For the temporary relief of symptoms associated with minor cuts and burns Directions Adults: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. Children: Use under the direction of your healthcare practitioner.
Uses For the temporary relief of symptoms associated with minor sprains and bruises. Directions Adults: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. Children: Use under the direction of your healthcare practitioner.
Purpose
Information about the drug product’s indications for use.Uses For the temporary relief of symptoms associated with minor cuts and burns
Uses For the temporary relief of symptoms associated with minor sprains and bruises.
Spl product data elements
Usually a list of ingredients in a drug product.Calendula Cream Calendula officinalis GLYCERIN CETOSTEARYL ALCOHOL CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP WATER ROSE OIL Arnica Cream Arnica montana ARNICA MONTANA ARNICA MONTANA CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP CETOSTEARYL ALCOHOL GLYCERIN WATER
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.NDC 62106-1177-0 UNDA topicals CALENDULA CREAM Homeopathic Preparation For the temporary relief of symptoms associated with minor cuts and burns. Net Weight 1.4 oz (40 g) 62106-1177-0
NDC 62106-1180-0 UNDA topicals ARNICA CREAM Homeopathic Preparation For the temporary relief of symptoms associated with minor sprains and bruises. Net Weight 1.4 oz. (40 g) Arnica Cream
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.
Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Do not use if inner seal is missing or broken. Store in a cool, dry place. Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity
Other information Do not use if inner seal is missing or broken. Store in a cool, dry place.
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. Stop use and ask a doctor if symptoms persist or worsen. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only. Do not use on irritated skin if excessive irritation develops When using this product, avoid getting into eyes or mucous membranes. Stop use and ask a doctor if symptoms persist or worsen. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison 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