Vivalacara Dermalere Advanced Skin Cream
FDA Label NDC 84871-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vivalacara Spa Products Inc. for the product Vivalacara Dermalere Advanced Skin Cream (NDC 84871-009). 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.

Label Section Quick Index

→ Active Ingredient Section

→ Purpose

→ Uses

→ Warning

→ Do Not Use

→ When Using

→ Keep Out Of Reach Of Children

→ Stop Use

→ Pregnancy Or Breast Feeding

→ Directions

→ Other Information

→ Inactive Ingredient Section

→ Questions And Disclaimer

→ Package Label.principal Display Panel

Active Ingredient Section

Calendula Officinalis 1X HPUS 5%

Chamomilla Recutita 1X HPUS 5%

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

Purpose

Healing and Skin Soothing

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, pressure, or wetness.

• Protects skin.

• Heals dry skin.

Warning

For external use only.

Do Not Use

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

When Using

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

Keep Out Of Reach Of Children

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

Stop Use

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

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

Directions

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

Other Information

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

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.