Black Rose by MAKRA KOZMETIKA D.O.O. Black Rose

Black Rose by

Drug Labeling and Warnings

Black Rose by is a Otc medication manufactured, distributed, or labeled by MAKRA KOZMETIKA D.O.O.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLACK ROSE- lanolin ointment 
MAKRA KOZMETIKA D.O.O.

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Black Rose

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

BLACK ROSE 
lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82806-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	249.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82806-001-01	1 in 1 CARTON	09/01/2022	12/31/2024
1		35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/01/2022	12/31/2024

Labeler - MAKRA KOZMETIKA D.O.O. (537064093)

Registrant - MAKRA KOZMETIKA D.O.O. (537064093)

Establishment
Name	Address	ID/FEI	Business Operations
MAKRA KOZMETIKA D.O.O.		537064093	manufacture(82806-001)

Revised: 10/2024

Document Id: 252aad91-df11-7e9b-e063-6294a90a0c2f

34390-5

Set id: e60c2c8b-3bad-57ac-e053-2995a90a2faa

Version: 4

Effective Time: 20241023