CUREFINI- petrolatum, cod liver oil ointment

CUREFINI by

Drug Labeling and Warnings

CUREFINI by is a Otc medication manufactured, distributed, or labeled by Miramar Cosmetic, Inc.. 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.

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.

SPL UNCLASSIFIED SECTION

PROPERTIES: CUREFINI is an ointment made with various well known vegetable and animal materials commonly found in the pharmacopeia. When they are combined together in certain proportions, the resulting compound has strong skin protection properties. CUREFINI has been found to provide therapeutic benefits in the treatment for diverse lesions of the skin, and helps restore the skin to its normal, healthy condition. Made of natural substances, CUREFINI does not contain corticoids or antibiotics. CUREFINI is used in a clinical environment to treat burns and wounds, and is also used as a household first-aid product to treat cuts, burns and scrapes.

Dermal Ointment for Skin Injuries, Cuts, Scrapes and Burns

ACCEPTED NATIONALECZEMA.ORG

NATIONAL ECZEMA ASSOCIATION

Clinically Tested Pediatrician Tested

Manufactured for: REV PHARMA CORP, 153 SW 22" Road, MIAMI, FL 33129, US Patent #10016466B2
Manufactured by: Miramar Lab 2301 NW 107th Ave, Ste 101 Doral, FL 33172, USA
*Color may vary due to organic yellow beeswax

Packaging

INGREDIENTS AND APPEARANCE

CUREFINI 
petrolatum, cod liver oil ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79974-202
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)
CHAMOMILE (UNII: FGL3685T2X)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79974-202-01	30 mL in 1 JAR; Type 0: Not a Combination Product	06/01/2022
2	NDC: 79974-202-02	60 mL in 1 JAR; Type 0: Not a Combination Product	06/01/2022
3	NDC: 79974-202-04	120 mL in 1 JAR; Type 0: Not a Combination Product	06/01/2022
4	NDC: 79974-202-08	240 mL in 1 JAR; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2022

Labeler - Miramar Cosmetic, Inc. (012873243)

Establishment
Name	Address	ID/FEI	Business Operations
Miramar Cosmetic, Inc.		012873243	manufacture(79974-202)