CICATRISAN CREAM- calendula officinalis, phytolacca decandra, bryonia dioica, balsamum peruvianum, dulcamara 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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CICATRISAN Cream

Active ingredients
This preparation contains:
Balsamum peruvianum
(Peruvian balsam) Balsam MT 1.0%
Bryonia dioica (Red bryony)
Root MT 1.0%
Calendula officinalis
(Marigold) Aerial Parts MT 1.0%
Dulcamara (Bittersweet)
Shoots MT 1.0%
Phytolacca decandra
(Pokeweed) Root MT 1.0%

Uses
For the temporary relief of symptoms
associated with minor skin irritations.

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
Boric acid, mineral oil, sorbitan
sesquioleate, white petrolatum

Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.

Uses
For the temporary relief of symptoms
associated with minor skin irritations.

Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.

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

62106-3152-0

NDC 62106-3152-0

UNDA topicals

CICATRISAN CREAM

Homeopathic Preparation

For the temporary relief of symptoms
associated with minor skin irritations.

Net Weight 1.4 oz. (40 g)

CICATRISAN CREAM 
calendula officinalis, phytolacca decandra, bryonia dioica, balsamum peruvianum, dulcamara cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-3152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY) BALSAM PERU1 [hp_X]  in 40 g
BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX) (BRYONIA DIOICA ROOT - UNII:53UB5FH7CX) BRYONIA DIOICA ROOT1 [hp_X]  in 40 g
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP1 [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
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT1 [hp_X]  in 40 g
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62106-3152-01 in 1 CARTON05/07/2015
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/07/2015
Labeler - Seroyal USA (018361118)
Establishment
NameAddressID/FEIBusiness Operations
SAN'UP401010287manufacture(62106-3152)

Revised: 7/2021
Document Id: c71eb176-d09b-45b3-e053-2a95a90a53df
Set id: 156ec27b-d27e-1739-e054-00144ff88e88
Version: 4
Effective Time: 20210714
 
Seroyal USA