Label: VIVALACARA DERMALERE PLUS ADVANCED BURN AND SCAR CREAM- allantoin cream

  • NDC Code(s): 84871-007-01
  • Packager: VivaLaCara Spa Products Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 21, 2024

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  • 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

    Dermalere Plus 40 mL Tube Template

    Dermalere Plus 40 mL Tube Template

  • INGREDIENTS AND APPEARANCE
    VIVALACARA DERMALERE PLUS ADVANCED BURN AND SCAR CREAM 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84871-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84871-007-011 in 1 BOX11/21/2024
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/21/2024
    Labeler - VivaLaCara Spa Products Inc. (202000418)
    Registrant - VivaLaCara Spa Products Inc. (202000418)
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