The following Structured Product Label (SPL) was submitted to the FDA by Vivalacara Spa Products Inc. for the product Vivalacara Dermalere Advanced Burn And Scar Cream (NDC 84871-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient section, purpose, uses, warning, do not use, when using, keep out of reach of children, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Healing, Skin Soothing
•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.
For external use only.
Do not use on deep or puncture wounds, animal bites or serious burns.
When using this product • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
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.
Consult a health care professional prior to use if you are pregnant or breastfeeding.
Keep in a dry place, away from direct sunlight in temperatures between 5°C to 28°C.
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? (Call) 1-888-371-8482 / [email protected]
*Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
**Homeopathic mother tincture is a 1x potency.
Adults, adolescents, and children 2 years of age and older: •Apply liberally to a clean and dry affected area as needed.
Vivalacara Dermalere Burn And Scar Cream_box_40g (Dermalere Homeopathic Box 40g 84871 008 01 Resized)
Natural Herbal Formula
DERMALERE
Advanced Burn and Scar Skin Cream
Calendula and Chamomile Homeopathic Medicine
40 g
* Please review the disclaimer below.
