Drugplain

Calendula Cream 1 [hp_X]/40g

Calendula officinalis · CREAM · Seroyal USA

1 Recall on Record
Plain English

Calendula Cream is a cream containing calendula officinalis at 1 [hp_X]/40g, taken topical. Manufactured by Seroyal USA.

Key Facts

Brand Name
Calendula Cream
Generic Name
Calendula officinalis
NDC Code (Product)
62106-1177
Manufacturer
Seroyal USA
Strength
1 [hp_X]/40g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
01/20/2015

Recall History

1 Recall on Record
Class III04/13/2018

Boiron Inc.

Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2 reports
erythema2 reports
febrile neutropenia2 reports
abdominal pain1 reports
acute vestibular syndrome1 reports
application site burn1 reports
arrhythmia1 reports
asthenia1 reports
back pain1 reports
blood pressure diastolic increased1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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.

Warnings

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.

Frequently Asked Questions

What is Calendula Cream used for?

Calendula Cream contains Calendula officinalis. It is a cream taken topical. Consult your doctor for specific uses.

Is Calendula Cream a controlled substance?

Calendula Cream is not classified as a controlled substance by the DEA.

What is the generic name for Calendula Cream?

The generic name for Calendula Cream is Calendula officinalis. There are 12 other brand versions of Calendula officinalis.

What is the NDC code for Calendula Cream 1 [hp_X]/40g?

The NDC (National Drug Code) for Calendula Cream 1 [hp_X]/40g is 62106-1177, listed by Seroyal USA.