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 package outer package

BLACK ROSE
lanolin ointment

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82806-001-01	1 in 1 CARTON	09/01/2022
1		35 g in 1 TUBE; Type 0: Not a Combination Product

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

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

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

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