Label: CICATRISAN CREAM- calendula officinalis, phytolacca decandra, bryonia dioica, balsamum peruvianum, dulcamara cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated July 14, 2021

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  • ACTIVE INGREDIENT

    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%

  • PURPOSE

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

  • 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
    Boric acid, mineral oil, sorbitan
    sesquioleate, white petrolatum

  • DOSAGE & ADMINISTRATION

    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.

  • INDICATIONS & USAGE

    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 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

  • PRINCIPAL DISPLAY PANEL

    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)

  • INGREDIENTS AND APPEARANCE
    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)
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