VivaLaCara Dermalere Advanced Burn and Scar Cream

Manufacturer
VivaLaCara Spa Products Inc. | Bodywell Natural Skin Care Inc.
Effective date
2025-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:31:29

Label at a glance#

ProductVivaLaCara Dermalere Advanced Burn and Scar Cream
Active ingredientCALENDULA OFFICINALIS FLOWER, CHAMOMILE
Label structure14 sections

Indications and uses

•Homeopathic formula to support natural healing of minor burns, scars, cuts, scrapes, and chafing. • Moisturizes to improve the appearance of recent minor scars. • Provides relief from mild sunburn discomfort. • Helps soothe itching and skin irritation, based on traditional homeopathic use. • Lubricates to temporarily protect and alleviate chapping, cracking, and roughness caused by dryness, prolonged friction, pr...

Dosage and administration

Adults, adolescents, and children 2 years of age and older: •Apply liberally to a clean and dry affected area as needed.

Storage and handling

Keep in a dry place, away from direct sunlight in temperatures between 5°C to 28°C.

Label contents#

Full prescribing information#

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis 1X HPUS 5% Purpose Healing agent

Chamomilla Recutita 1X HPUS 5% Purpose Skin Soothing agent

The letters "HPUS" indicate that the ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Healing, Skin Soothing

Uses

INDICATIONS & USAGE SECTION

•Homeopathic formula to support natural healing of minor burns, scars, cuts, scrapes, and chafing.

• Moisturizes to improve the appearance of recent minor scars.

• Provides relief from mild sunburn discomfort.

• Helps soothe itching and skin irritation, based on traditional homeopathic use.

• Lubricates to temporarily protect and alleviate chapping, cracking, and roughness caused by dryness, prolonged friction, pressure, or wetness.

• Protects skin.

• Heals dry skin.

Warning

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When using

OTC - WHEN USING SECTION

When using this product • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Stop use

OTC - STOP USE SECTION

Stop use and ask a health care practitioner if symptoms worsen, last for more than 7 days, or clear up and occur again within a few days.

Stop use if hypersensitivity/ allergy or irritation occurs.

Pregnancy or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a health care professional prior to use if you are pregnant or breastfeeding.

Other information

STORAGE AND HANDLING SECTION

Keep in a dry place, away from direct sunlight in temperatures between 5°C to 28°C.

Mon-medicinal ingredients

INACTIVE INGREDIENT SECTION

Aqua, Cocos Nucifera (Coconut) Oil, Stearic Acid, Alcohol, Oleyl Erucate, Helianthus Annuus (Sunflower) Seed Oil, Stearyl Alcohol, Glyceryl Stearate, Euphorbia Cerifera (Candelilla) Wax, Caprylic/Capric Triglycerides, Hydroxypropyl Starch Phosphate, Arginine, Hydrogenated Castor Oil Dehydroacetic Acid, Xanthan Gum, Panthenol, Plantago Major Leaf Extract, Rhus Cotinus Leaf Extract, Urtica Dioica (Nettle) Extract, Aloe Barbadensis Leaf Juice.

Questions and Disclaimer

OTC - QUESTIONS SECTION

Questions? (Call) 1-888-371-8482 / info@vivalacara.com

*Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

**Homeopathic mother tincture is a 1x potency.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults, adolescents, and children 2 years of age and older: •Apply liberally to a clean and dry affected area as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VivaLaCara Dermalere Burn and Scar Cream_Box_40gVivaLaCara Dermalere Burn and Scar Cream_Box_40gNDC 84871-008-01

Natural Herbal Formula

DERMALERE

Advanced Burn and Scar Skin Cream

Calendula and Chamomile Homeopathic Medicine

40 g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84871-008-01VivaLaCara Dermalere Advanced Burn and Scar Cream1 in 1 BOXCREAM11
84871-008-01VivaLaCara Dermalere Advanced Burn and Scar Cream40 g in 1 TUBECREAM401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84871-008VIVALACARA DERMALERE ADVANCED BURN AND SCAR CREAM (CALENDULA AND CHAMOMILE HOMEOPATHIC MEDICINE) CREAM [VIVALACARA SPA PRODUCTS INC.]1Current NDC, 2 package rows20250120_2c13f7a1-a8b4-eebb-e063-6394a90a2ae5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84871-00884871-008-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VivaLaCara Dermalere Advanced Burn and Scar CreamCALENDULA AND CHAMOMILE HOMEOPATHIC MEDICINEVivaLaCara Spa Products Inc.2c13f7a1-a8b4-eebb-e063-6394a90a2ae52025-01-19WarningsExact identifier
ndc (package): 84871-008-01
ndc (product): 84871-008
ndc11 (package): 84871000801
spl id: 2c13f7a1-a8b5-eebb-e063-6394a90a2ae5
spl set id: 2c13f7a1-a8b4-eebb-e063-6394a90a2ae5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.