SPL v1
SPL
SPL Set ID 2c30c12c-1265-952c-e063-6294a90ab2ac
Route
TOPICAL
Published
Effective Date 2025-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flower (5 g) Chamomile
Inactive Ingredients
Cocos Nucifera (coconut) Oil Aqua Stearyl Alcohol Xanthan Gum Arginine Hydrogenated Castor Oil Stearic Acid Helianthus Annuus (sunflower) Seed Oil Glyceryl Monostearate Urtica Dioica Leaf Cotinus Coggygria Leaf Dexpanthenol Euphorbia Cerifera (candelilla) Wax Caprylic/capric Triglyceride Dehydroacetic Acid Aloe Vera Leaf Oleyl Erucate Alcohol Plantago Major Leaf Starch, Corn

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-01-21

Description

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


Medication Information

Purpose

Healing and Skin Soothing

Description

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.

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.

Section 51945-4

VivaLaCara Logo NDC 84871-006-02 / NPN 80106111

Natural Herbal Formula

DERMALERE

Advanced Skin Cream

Calendula and Chamomile Homeopathic Medicine

Soothes • Heals • Protects

1.76 oz. (50 g)

Topical Cream

Warning

For external use only.

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.

Directions

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

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.

Other Information

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

Questions and Disclaimer

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.

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.

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.

Pregnancy Or Breast Feeding

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

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.


Structured Label Content

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.

Section 51945-4 (51945-4)

VivaLaCara Logo NDC 84871-006-02 / NPN 80106111

Natural Herbal Formula

DERMALERE

Advanced Skin Cream

Calendula and Chamomile Homeopathic Medicine

Soothes • Heals • Protects

1.76 oz. (50 g)

Topical Cream

Purpose

Healing and Skin Soothing

Warning

For external use only.

Stop Use (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.

Directions

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

Do Not Use (Do not use)

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

When Using (When using)

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

Other Information (Other information)

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

Questions and Disclaimer

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.

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.

Inactive Ingredient Section (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.

Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

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

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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