VivaLaCara Dermalere Advanced Skin Cream by Bodywell Natural Skin Care Inc

VivaLaCara Dermalere Advanced Skin Cream by

Drug Labeling and Warnings

VivaLaCara Dermalere Advanced Skin Cream by is a Homeopathic medication manufactured, distributed, or labeled by Bodywell Natural Skin Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81441-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L)	COCONUT OIL	6 g  in 100 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1 g  in 100 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 g  in 100 mL
SUNFLOWER OIL (UNII: 3W1JG795YI) (SUNFLOWER OIL - UNII:3W1JG795YI)	SUNFLOWER OIL	2 g  in 100 mL
DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z)	DEXPANTHENOL	0.1 g  in 100 mL
URTICA DIOICA LEAF (UNII: X6M0DRN46Q) (URTICA DIOICA LEAF - UNII:X6M0DRN46Q)	URTICA DIOICA LEAF	0.02 g  in 100 mL
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X) (PLANTAGO MAJOR LEAF - UNII:7DC28K241X)	PLANTAGO MAJOR LEAF	0.02 g  in 100 mL
COTINUS COGGYGRIA LEAF (UNII: 8FBI9JDF22) (COTINUS COGGYGRIA LEAF - UNII:8FBI9JDF22)	COTINUS COGGYGRIA LEAF	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81441-006-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/24/2021
2	NDC: 81441-006-02	40 mL in 1 TUBE; Type 0: Not a Combination Product	03/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/24/2021	07/26/2022

Labeler - Bodywell Natural Skin Care Inc (201162026)

Establishment
Name	Address	ID/FEI	Business Operations
Bodywell Natural Skin Care Inc		201162026	manufacture(81441-006)

Revised: 1/2025

Document Id: 2c78cca2-485e-ff75-e063-6394a90a4ed4

34390-5

Set id: 4e283005-8707-4bee-a9c0-9dd146c1b06b

Version: 3

Effective Time: 20250124