Label: AVANCE CURE BARRIER- allantoin, dimethicone, menthol cream

  • NDC Code(s): 70936-106-11, 70936-106-12, 70936-106-22
  • Packager: SMART CHOICE MEDICAL INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • ACTIVE INGREDIENT:

    • ALLANTOIN              0.5%
    • DIMETHICONE         2%
    • MENTHOL                0.45%
  • PURPOSE:

    SKIN PROTECTANT

    SKIN PROTECTANT

    TOPICAL ANALGESIC

  • USES

    • HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN/MINOR SKIN IRRITATION DUE TO/ASSOCATED WITH DIAPER RASH
    • HELPS PROTECTS FROM/SEAL OUT WETNESS
    • TEMPORARLY PROTECTS AND HELPS RELEIVE CHAFED, CHAPPED, OR CRACKED SKIN
  • WARNINGS:

    • FOR EXTERNAL ONLY

    DO NOT USE:

    • ON DEEP PUNCTURE WOUNDS
    • ON INFECTIONS
    • ON LACERATIONS

    WHEN USING THIS PRODUCT:

    • AVOID CONTACT WITH EYES

    STOP USE AND ASK A DOCTOR IF:

    • CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDERN:

    • IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY
  • DIRECTIONS:

    GENTLY CLEAN THE IRRITATED AREA BEFORE USE. THEN APPLY A GENEROUS LAYER OF CREAM.

    IT CAN BE LEFT ON THICK OR RUBBED INTO SKIN. USEAS MANY TIMES A DAY AS NECESSARY

    UNTIL HEALED. FOR CONTINUOUS PROTECTION AND HEALTHY SKIN USE DAILY.

  • INACTIVE INGREDIENTS:

    ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, BUTYROSPERMUN PARKII (SHEA BUTTER), GLYCERIN,

    BEESWAX, CETEARYL ALCOHOL, CARTHAMUS TINDORIUS (SAFFLOWER) SEED OIL, POLYSORBATE 60,

    MAGNESIUM ALUMINUM SILICATE, CALAMINE, ZINC PCA, AVENA SATIVA (OAT) KERNEL FLOUR, SODIUM PCA,

    PANTHENOL (VITAMIN B5), TOCOPHERYL ACETATE (VITAMIN E), SODIUM HYALURONATE, GLYCERYL STEARATE,

    SOBIC ACID, SODIUM PHYTATE, XANTHAN GUM, PHENOXYETHANOL, ETHYHEXYLGLYCERIN

  • PRINCIPAL DISPLAY PANEL

    AvanceCureBarrier

    AvanceCureBarrier_Tube

  • INGREDIENTS AND APPEARANCE
    AVANCE CURE BARRIER 
    allantoin, dimethicone, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70936-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.45 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70936-106-11135 g in 1 TUBE; Type 0: Not a Combination Product08/22/2016
    2NDC:70936-106-12270 g in 1 TUBE; Type 0: Not a Combination Product08/22/2016
    3NDC:70936-106-22270 g in 1 JAR; Type 0: Not a Combination Product08/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/22/2016
    Labeler - SMART CHOICE MEDICAL INC. (046383276)
    Registrant - SMART CHOICE MEDICAL INC. (046383276)
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