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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Unda Creams

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.

62106-1177-0

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)

62106-1180-0

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)

CALENDULA CREAM 
calendula officinalis cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1177
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 40 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
ROSE OIL (UNII: WUB68Y35M7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62106-1177-01 in 1 CARTON01/20/2015
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/20/2015
ARNICA CREAM 
arnica montana cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 40 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 40 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62106-1180-01 in 1 CARTON01/20/2015
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/20/2015
Labeler - Seroyal USA (018361118)
Establishment
NameAddressID/FEIBusiness Operations
SAN'UP401010287manufacture(62106-1177, 62106-1180)

Revised: 7/2021
Document Id: c7344df0-9358-5f44-e053-2a95a90a1d90
Set id: 079c4f1c-836d-1113-e054-00144ff8d46c
Version: 10
Effective Time: 20210715
 
Seroyal USA