Label: HEALING CREAM- borneol cream

  • NDC Code(s): 84019-002-01
  • Packager: Shengnan (Guangzhou) Cosmetics Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 23, 2024

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  • ACTIVE INGREDIENT

    borneol 2%

  • Purpose

    Helps promote healing of cuts.scrapes &chafing

  • Warnings

    This product shouldnot be used by children.For externaluse only.Avoid direct contact with eyes

  • Stop use and ask a doctor if

    rash occurs

  • Do not use

    Appearing allergic conditions

  • When using this product

    keep out of eyes: Rinse with water to remove

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Water
    mineral oil

    glycerin
    cyclopentasiloxane

    steareth-21
    glyceryl stearate
    cetearyl alcohol
    urea

    steareth-2

    dimethicone

    peg-100 glyceryl stearate

    caprylic
    phenoxyethanol

    bisabolol

    hydroxyethylcellulos

    tocopherol

    panthenol

    disodium edta

  • DOSAGE & ADMINISTRATION

    Apply appropriate dêrmatitis cream amount to desired areasand massage until fully absorbed. Twice a day.

  • INDICATIONS & USAGE

    Apply appropriate dêrmatitis cream amount to desired

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HEALING CREAM 
    borneol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84019-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DODECANEDIOIC ACID (UNII: 978YU42Q6I)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    WATER (UNII: 059QF0KO0R)  
    (4-(TRIFLUOROMETHOXY)PHENYL)UREA (UNII: SQP4E8O29W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84019-002-011 in 1 BOX05/23/2024
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/23/2024
    Labeler - Shengnan (Guangzhou) Cosmetics Co., LTD (541200425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengnan (Guangzhou) Cosmetics Co., LTD541200425manufacture(84019-002)
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