Label: BLACK ROSE- lanolin ointment

  • NDC Code(s): 82806-001-01
  • Packager: MAKRA KOZMETIKA D.O.O.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts

  • Active ingredient

    Lanolin 24.91%

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects minor:
    • temporarily protects chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather

    • cuts

    • scrapes

    • burns

  • Warnings

    For external use only.

    Do not use

    • on deep or puncture wounds
    • on animal bites
    • on serious burns
  • When using this product

    do not get into eyes

  • Stop use and ask a doctor if

    condition worsens

    symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    apply as needed

  • Inactive ingredients

    Water, petrolatum, olive (Olea europea) fruit oil, calendula (Calendula officinalis) flower extract, almond (Prunus dulcis) oil, cetearyl alcohol, jojoba (Simmondsia chinesis) seed oil, sodium benzoate, potassium sorbate, bisabolol, allantoin, tocopheryl acetate, retinyl palmitate, sodium cetearyl sulfate, coumarin, sodium lauryl sulfate, benzyl cinnamate, citric acid, fragrance, cinnamyl alcohol and citronellol.

  • Tattoo Care Black Rose Skin Protectant Ointment, 1.2 oz (35g) 82806-100-01

    inner packageouter package

  • INGREDIENTS AND APPEARANCE
    BLACK ROSE 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82806-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN249.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    COUMARIN (UNII: A4VZ22K1WT)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82806-001-011 in 1 CARTON09/01/2022
    135 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2022
    Labeler - MAKRA KOZMETIKA D.O.O. (537064093)
    Registrant - MAKRA KOZMETIKA D.O.O. (537064093)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAKRA KOZMETIKA D.O.O.537064093manufacture(82806-001)
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