Label: VIVALACARA DERMALERE ADVANCED BURN AND SCAR CREAM- coconut, chamomile, sunflower oil, dexpanthenol, plantago major, urtica dioica, cotinus coggygria,calendula officinalis flower cream
- NDC Code(s): 81441-007-01
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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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. Chamomilla Matricaria is used in Herbal
Medicine to help relieve minor inflammation/or irritation ofthe 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.
Do not use this product if you are pregnant or breastfeeding.
Stop use if hypersensitivity/allergy or irritation occurs.
- Keep out of reach of children.
- Directions.
- Other Information.
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Inactive Ingredients.
Purified water(Water) Stearic Acid,( Palm Oil), Alcohoi(Corn Sugar), Oleyl
Erucate(Rapeseed Oi l), Stearyl Alcohoi(Palm Oil), Glyceryl Monostearate(Palm Oil),
Euphorbia Cerifera(Candelilla) Wax(Candelilla Plant), Capric/Caprylic
Triglycerides(Coconut Oil), Hydroxypropyl Starch Phosphate(Corn Starch), LArginine(
Giycine ~ax Plant), Hydrogenated Castor Oii(Castor Oil Plant), Dehydroacetic
Acid(Organic Compound), Xanthan Gum(Giucose), Aloe Barbadensis Leaf Juice(Aioe
Barbadensis Leaf) - Product label
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INGREDIENTS AND APPEARANCE
VIVALACARA DERMALERE ADVANCED BURN AND SCAR CREAM
coconut, chamomile, sunflower oil, dexpanthenol, plantago major, urtica dioica, cotinus coggygria,calendula officinalis flower creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81441-007 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:81441-007-01 40 mL in 1 TUBE; Type 0: Not a Combination Product 04/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/02/2021 Labeler - Bodywell Natural Skin Care Inc (201162026) Establishment Name Address ID/FEI Business Operations Bodywell Natural Skin Care Inc 201162026 manufacture(81441-007)
