Label: VIVALACARA DERMALERE ADVANCED SKIN CREAM- coconut, german chamomile, pot-marigold, helianthus annuus, d-panthenol, plantago major, urtica dioica, cotinus coggygria cream

  • NDC Code(s): 81441-006-01, 81441-006-02
  • Packager: Bodywell Natural Skin Care Inc
  • 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 January 17, 2023

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  • Active Ingredients

    Cocos nucifera, German chamomile, Pot-marigold, Helianthus Annuus, D-Panthenol, Plantago major, Urtica dioica, Cotinus coggygria

  • Purpose

    Fast Healing of Wounds & Damaged Skin
    Quick Relief of Skin Inflammation & Irritation
    Badge - made with calendula and chamomile

    Lubricates, protects, and soothes dry, cracked, and chafed skin.
    Moisturizes and improves the look of recent scars.

  • Uses

    This product contains Calendula. Calendula officinalis is traditionally used in Herbal Medicine to aid in wound healing and help relieve skin inflammations and irritations. This product contains German Chamomile. Matricaria chamomilla is used in Herbal Medicine to help relieve minor inflammation/or irritation of the skin.

  • Warnings

    For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult a health care professional if symptoms worsen or last for more than 7 days. Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Stop use if hypersensitivity/allergy or irritation occurs. Do not use this product if you are pregnant or breastfeeding.

  • Keep out of reach of children.

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

  • Directions.

    Adults: Apply to affected area as needed.

  • Other Information.

    Do not use on deep or puncture wounds, animal bites or serious burns.

  • Inactive Ingredients.

    Purified water (Water), Stearic acid (Palm Oil), Alcohol (Corn Sugar), Oleyl erucate (Rapeseed Oil), Stearyl alcohol (Palm Oil), Glyceryl monostearate (Palm Oil), Euphorbia Cerifera (Candelilla) Wax (Candelilla Plant), Caprylic/capric triglyceride (Coconut Oil)
    Hydroxypropyl starch phosphate (Corn Starch) ,L-Arginine (Glycine Max Plant) ,Hydrogenated castor oil (Castor Oil Plant), Dehydroacetic Acid (Organic Compound), Xanthan Gum (Glucose),Aloe Barbadensis Leaf Juice (Aloe Barbadensis Leaf).

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    VIVALACARA DERMALERE ADVANCED SKIN CREAM 
    coconut, german chamomile, pot-marigold, helianthus annuus, d-panthenol, plantago major, urtica dioica, cotinus coggygria cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81441-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L) COCONUT OIL6 g  in 100 mL
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE1 g  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 g  in 100 mL
    SUNFLOWER OIL (UNII: 3W1JG795YI) (SUNFLOWER OIL - UNII:3W1JG795YI) SUNFLOWER OIL2 g  in 100 mL
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL0.1 g  in 100 mL
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q) (URTICA DIOICA LEAF - UNII:X6M0DRN46Q) URTICA DIOICA LEAF0.02 g  in 100 mL
    PLANTAGO MAJOR LEAF (UNII: 7DC28K241X) (PLANTAGO MAJOR LEAF - UNII:7DC28K241X) PLANTAGO MAJOR LEAF0.02 g  in 100 mL
    COTINUS COGGYGRIA LEAF (UNII: 8FBI9JDF22) (COTINUS COGGYGRIA LEAF - UNII:8FBI9JDF22) COTINUS COGGYGRIA LEAF0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALCOHOL (UNII: 3K9958V90M)  
    OLEYL ERUCATE (UNII: 753W099NQ6)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ARGININE (UNII: 94ZLA3W45F)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81441-006-0150 mL in 1 TUBE; Type 0: Not a Combination Product03/24/2021
    2NDC:81441-006-0240 mL in 1 TUBE; Type 0: Not a Combination Product03/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/24/2021
    Labeler - Bodywell Natural Skin Care Inc (201162026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bodywell Natural Skin Care Inc201162026manufacture(81441-006)
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