CUREFINI- petrolatum, cod liver ointment

Curefini by

Drug Labeling and Warnings

Curefini by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredients:

Petrolatum 30.00%

Cod Liver Oil 10.00 %

Purpose:

Skin Protectant

Uses:

• Temporarily protects minor cuts, scrapes and burns.
• Temporarily protects chapped or cracked skin.
• Helps protect from drying effects of wind and cold weather.

Warnings:

For external use only.

When using this product

• do not get into eyes.
• If condition worsens or does not improve for seven days, discontinue use and consult a physician.

DO NOT USE 

IF  TAMPER EVIDENT SEAL IS BROKEN.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Other information:

Store at room temperature.

Directions

Apply as needed. Prepare a gauze bandage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with a spatula, covering the entire surface with a thin layer. Place bandage directly on top of affected area. Make sure affected area remains covered by ointment.

Inactive Ingredients:

Beeswax, BHT, Chamomilla Recutita (Chamomile) Oil, Helianthus Annuus (Sunflower) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil.

Package Labeling:

INGREDIENTS AND APPEARANCE

CUREFINI 
petrolatum, cod liver ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-712
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	300 mg  in 1 mL
COD LIVER OIL (UNII: BBL281NWFG) (COD LIVER OIL - UNII:BBL281NWFG)	COD LIVER OIL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-712-65	240 mL in 1 JAR; Type 0: Not a Combination Product	02/07/2017
2	NDC: 65121-712-64	120 mL in 1 JAR; Type 0: Not a Combination Product	02/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/17/2013

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-712)