Arnica Cream

Manufacturer
Seroyal USA | SAN'UP
Effective date
2022-04-12
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 02:17:19

Label at a glance#

ProductCalendula Cream
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA
Label structure20 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Calendula officinalis (Marigold) Aerial Parts MT 5.0%

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with minor cuts and burns

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

If swallowed, get medical help or contact a Poison
Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Cetostearyl alcohol, glycerin, purified water, rose oil

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION SECTION

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.

INDICATIONS & USAGE SECTION

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.

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
This preparation contains:
Arnica montana (Mountain arnica)
Aerial Parts MT 5.0%
Calendula officinalis (Marigold)
Aerial Parts MT 2.0%

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with

minor sprains and bruises.

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

If swallowed, get medical help or contact a Poison
Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Cetostearyl alcohol, glycerin, purified water

OTHER SAFETY INFORMATION

Other information
Do not use if inner seal is missing or
broken.
Store in a cool, dry place.

DOSAGE & ADMINISTRATION SECTION

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.

INDICATIONS & USAGE SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-1177-062106-1177-0

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62106-1180-0

UNDA topicals

ARNICA CREAM

Arnica CreamArnica Cream

Homeopathic Preparation

For the temporary relief of symptoms associated
with minor sprains and bruises.

Net Weight 1.4 oz. (40 g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1177-0Calendula Cream40 g in 1 TUBECREAM4011
62106-1177-0Calendula Cream1 in 1 CARTONCREAM111
62106-1180-0Arnica Cream1 in 1 CARTONCREAM111
62106-1180-0Arnica Cream40 g in 1 TUBECREAM4011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1177CALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]11Current NDC, Legacy NDC, 2 package rows20220413_079c4f1c-836d-1113-e054-00144ff8d46c.zip
62106-1180CALENDULA CREAM (CALENDULA OFFICINALIS) CREAM ARNICA CREAM (ARNICA MONTANA) CREAM [SEROYAL USA]11Current NDC, Legacy NDC, 2 package rows20220413_079c4f1c-836d-1113-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW5
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ5
ARNICA MONTANAACTIVE MOIETYO80TY208ZW5
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S5
GLYCERININACTIVE INGREDIENTPDC6A3C0OX5
ROSE OILINACTIVE INGREDIENTWUB68Y35M75
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-117762106-1177-0
62106-118062106-1180-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calendula CreamCALENDULA OFFICINALISSeroyal USA079c4f1c-836d-1113-e054-00144ff8d46c2022-04-12WarningsExact identifier
ndc (package): 62106-1177-0
ndc (package): 62106-1180-0
ndc (product): 62106-1177
ndc (product): 62106-1180
ndc11 (package): 62106117700
ndc11 (package): 62106118000
spl id: dc794e74-8ef3-7942-e053-2a95a90a2bea
spl set id: 079c4f1c-836d-1113-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.