Indications and uses
USES: Temporary Relief - Discomfort During Wound Healing* * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
CALENDULA OFF
- Manufacturer
- Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
- Effective date
- 2024-06-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:27:11
Label at a glance#
ProductCALENDULA OFF
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections
Storage and handling
Store in a cool dark place
Contacts and useful links#
Websitewww.rxhomeo.com
www.Rxhomeo.com
www.Rxhomeo.comLabel contents#
Full prescribing information#
ACTIVE INGREDIENT
CALENDULA OFF HPUS 1X and higher
USES
USES: Temporary Relief - Discomfort During Wound Healing*
* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
INDICATIONS
Condition listed above or as directed by the physician
DOSAGE
Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.
WARNINGS
This product is to be used for self-limiting conditions
OTC - STOP USE SECTION
If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional
OTC - PREGNANCY OR BREAST FEEDING SECTION
As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all medication out of reach of children
OTC - DO NOT USE SECTION
Do not use if capseal is broken or missing.
Close the cap tightly after use.
INACTIVE INGREDIENTS
Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.
STORAGE
Store in a cool dark place
QUESTIONS OR COMMENTS
www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com - Rxhomeo, Inc 2940 Eisenhower St., Suite 100, Carrollton, TX 75007 USA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15631-2652-0 | CALENDULA OFF | 10 mL in 1 BOTTLE | LIQUID | 10 | 1 | |
| 15631-2652-1 | CALENDULA OFF | 30 mL in 1 BOTTLE | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 15631-2652 | CALENDULA OFF LIQUID [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC] | 1 | Current NDC, 2 package rows | 20240606_1a0d4a72-92f0-40e8-e063-6294a90a71f6.zip |
Products#
Every source-derived product name is available through these pages.
- CALENDULA OFF
- ALCOHOL
- WATER
- CALENDULA OFFICINALIS FLOWERING TOP
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 15631-2652 | 15631-2652-0, 15631-2652-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CALENDULA OFF | CALENDULA OFF | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 1a0d4a72-92f0-40e8-e063-6294a90a71f6 | 2024-06-04 | Warnings | 15631-2652-1 15631-2652-0 15631-2652 15631265201 15631265200 1a0d43c2-9f3f-4ae1-e063-6294a90a619a 1a0d4a72-92f0-40e8-e063-6294a90a71f6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.