VIVALACARA DERMALERE PLUS ADVANCED BURN AND SCAR CREAM- allantoin cream

VivaLaCara Dermalere Plus Advanced Burn and Scar Cream by

Drug Labeling and Warnings

VivaLaCara Dermalere Plus Advanced Burn and Scar Cream by is a Otc medication manufactured, distributed, or labeled by VivaLaCara Spa Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Medicinal Ingredients (w/w)

Allantoin 1%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to minor cuts, scrapes and burns Helps prevent and treat diaper rash Protects minor skin irritation due to diaper rash Helps protect from wetness that causes diaper rash Temporarily helps relieve minor skin irritation due to diaper rash Helps prevent and protect from the drying effects of wind and cold weather Soothes dry skin Protects chafed, chapped or cracked skin and lips.

Warning

For external use only.

Do not use

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

When using this product

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 and ask a health care practitioner

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.

Directions

Adults, adolescents, children, and infants: Apply liberally to a clean and dry diaper/affected area as needed.

Other information

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

Non-medicinal ingredients

Aqua

Cocos Nucifera (Coconut) Oil

Chamomilla Recutita (Matricaria) Flower Extract

Calendula Officinalis Flower Extract

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

Questions? (Call) 1-888-371-8482

Dosage & Administration

Topical cream

Principal Display Panel

Skin Protectant

Protectrice Pour La Peau

40 mL 1.35 fl. oz. U.S.

Natural Topical Cream

Dermalere Plus Advanced Burn and Scar Cream

Crème Avancée pour les Brûlures et les Cicatrices

INGREDIENTS AND APPEARANCE

VIVALACARA DERMALERE PLUS ADVANCED BURN AND SCAR CREAM 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84871-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CANDELILLA WAX (UNII: WL0328HX19)
COTINUS COGGYGRIA LEAF (UNII: 8FBI9JDF22)
ARGININE (UNII: 94ZLA3W45F)
OLEYL ERUCATE (UNII: 753W099NQ6)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STARCH, CORN (UNII: O8232NY3SJ)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
COCONUT OIL (UNII: Q9L0O73W7L)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84871-007-01	1 in 1 BOX	11/21/2024
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/21/2024

Labeler - VivaLaCara Spa Products Inc. (202000418)

Registrant - VivaLaCara Spa Products Inc. (202000418)