DRUG FACTS:

Active Ingredient:

Petrolatum 30.00%

Purpose

Skin Protectant

USES:

For temporary protection of minor cuts, scrapes and burns.
For temporary protection of cracked and chapped skin.
Helps protect from drying caused by wind and cold weather.

WARNINGS:

For external use only

Avoid contact with eyes.
If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not use

if tamper evident seal is broken.

Directions:

Apply daily over the affected area, with soft massages to ease absorption. Repeat application as many times as needed to keep skin permanently moisturized.

Other information:

Store at room temperature.
Do not use if tamper evident seal is broken.

Inactive Ingredients:

Aqua (Deionized Water), Beeswax, Cetearyl Alcohol, Cetearyl Olivate, Cetearyl Glucoside, Chamomilla Recutitta (Chamomile) Extract, Chamomilla Recutitta (Chamomile) Oil, Cocamidopropyl Betaine, Ethylhexylglycerin, Gadi Lecur (Cod Liver) Oil, Helianthus Annuus ( Sunflower) Seed Oil, Phenoxyethanol, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E).

Questions?

(M-F) (9-5pm EST)

Package Labeling: 177.441mL (69981-729-01)

Bottle

Package Labeling:90ml (69981-729-03)

Label2

CUREFINI DERMAL
petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69981-729
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	300 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CHAMOMILE (UNII: FGL3685T2X)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
COD LIVER OIL (UNII: BBL281NWFG)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69981-729-01	1 in 1 BOX	02/08/2017
1		177.441 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:69981-729-03	90 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	02/08/2017

Labeler - Rev Pharma Corp. (079422405)

Curefini Dermal Cream