OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Calendula officinalis (Marigold) Aerial Parts MT 5.0%
Active ingredients
Calendula officinalis (Marigold) Aerial Parts MT 5.0%
Uses
For the temporary relief of symptoms associated with minor cuts and burns
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison
Control Center right away.
Inactive ingredients
Cetostearyl alcohol, glycerin, purified water, rose oil
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
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 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.
Active ingredients
This preparation contains:
Arnica montana (Mountain arnica)
Aerial Parts MT 5.0%
Calendula officinalis (Marigold)
Aerial Parts MT 2.0%
Uses
For the temporary relief of symptoms associated with
minor sprains and bruises.
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison
Control Center right away.
Inactive ingredients
Cetostearyl alcohol, glycerin, purified water
Other information
Do not use if inner seal is missing or
broken.
Store in a cool, dry place.
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.
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)
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)
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62106-1177-0 | Calendula Cream | 40 g in 1 TUBE | CREAM | 40 | 11 | |
| 62106-1177-0 | Calendula Cream | 1 in 1 CARTON | CREAM | 1 | 11 | |
| 62106-1180-0 | Arnica Cream | 1 in 1 CARTON | CREAM | 1 | 11 | |
| 62106-1180-0 | Arnica Cream | 40 g in 1 TUBE | CREAM | 40 | 11 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62106-1177 | CALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA] | 11 | Current NDC, Legacy NDC, 2 package rows | 20220413_079c4f1c-836d-1113-e054-00144ff8d46c.zip |
| 62106-1180 | CALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA] | 11 | Current NDC, Legacy NDC, 2 package rows | 20220413_079c4f1c-836d-1113-e054-00144ff8d46c.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARNICA MONTANA | ACTIVE INGREDIENT | O80TY208ZW | 5 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE INGREDIENT | 18E7415PXQ | 5 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | 5 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE MOIETY | 18E7415PXQ | 5 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 5 | |
| ROSE OIL | INACTIVE INGREDIENT | WUB68Y35M7 | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62106-1177 | 62106-1177-0 |
| 62106-1180 | 62106-1180-0 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ROSE OIL | WUB68Y35M7 | IACT |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg |
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 Cream | CALENDULA OFFICINALIS | Seroyal USA | 079c4f1c-836d-1113-e054-00144ff8d46c | 2022-04-12 | Warnings | 62106-1177-0 62106-1180-0 62106-1177 62106-1180 62106117700 62106118000 dc794e74-8ef3-7942-e053-2a95a90a2bea 079c4f1c-836d-1113-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.