FDA.reportPublic FDA data

Black Rose

Manufacturer
MAKRA KOZMETIKA D.O.O.
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:51:25

Label at a glance#

ProductBlack Rose
Active ingredientLANOLIN
Label structure9 sections

Indications and uses

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

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lanolin 24.91%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

• cuts

• scrapes

• burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on deep or puncture wounds
  • on animal bites
  • on serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

inner packageinner packageouter packageouter package

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82806-00182806-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
OLIVE OIL6UYK2W1W1EIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ALMOND OIL66YXD4DKO9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
JOJOBA OIL724GKU717MIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
COUMARINA4VZ22K1WTIACT
SODIUM LAURYL SULFATE368GB5141JIACT
BENZYL CINNAMATEV67O3RO97UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CINNAMYL ALCOHOLSS8YOP444FIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LANOLIN7EV65EAW6HACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
252aad91-df11-7e9b-e063-6294a90a0c2fe60c2c8b-3bad-57ac-e053-2995a90a2faa2024-10-23WarningsExact identifier
spl id: 252aad91-df11-7e9b-e063-6294a90a0c2f
spl set id: e60c2c8b-3bad-57ac-e053-2995a90a2faa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.