VIVALACARA DERMALERE ADVANCED SKIN CREAM- coconut, german chamomile, pot-marigold, helianthus annuus, d-panthenol, plantago major, urtica dioica, cotinus coggygria cream 
Bodywell Natural Skin Care Inc

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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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

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)

Revised: 1/2023
Document Id: f2771849-c893-b834-e053-2995a90a69e3
Set id: 4e283005-8707-4bee-a9c0-9dd146c1b06b
Version: 2
Effective Time: 20230117
 
Bodywell Natural Skin Care Inc