CALENDULA CREAM- calendula officinalis cream ARNICA CREAM- arnica montana cream

Arnica Cream by

Drug Labeling and Warnings

Arnica Cream by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

INACTIVE INGREDIENT

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.

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.

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.

ACTIVE INGREDIENT

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

PURPOSE

Uses
For the temporary relief of symptoms associated with

minor sprains and bruises.

WARNINGS

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

Keep out of reach of children.

OVERDOSAGE

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

INACTIVE INGREDIENT

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

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

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.

PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

CALENDULA CREAM 
calendula officinalis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-1177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 40 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
ROSE OIL (UNII: WUB68Y35M7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-1177-0	1 in 1 CARTON	01/20/2015
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/20/2015

ARNICA CREAM 
arnica montana cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-1180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 40 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 40 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-1180-0	1 in 1 CARTON	01/20/2015
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/20/2015

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-1177, 62106-1180)