CUREFINI DERMAL- petrolatum, cod liver cream
Rev Pharma Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CUREFINI Dermal Ointment

Drug Facts:

Active Ingredients:

Petrolatum 30.00% Cod Liver Oil 10.00%

(Skin Protectant)

Uses:

Temporarily protects of 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 NOTUSE 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 Annus (Sunflower) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil.

Package Labeling: 30ml

Label

Package Labeling: 60ml

Label2

Package Labeling: 120ml

Label3

Package Labeling: 240ml

Label4

CUREFINI DERMAL
petrolatum, cod liver cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69981-704
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
COD LIVER OIL (UNII: BBL281NWFG) (COD LIVER OIL - UNII:BBL281NWFG)	COD LIVER OIL	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
CHAMOMILE (UNII: FGL3685T2X)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
ALMOND OIL (UNII: 66YXD4DKO9)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69981-704-01	30 mL in 1 JAR; Type 0: Not a Combination Product	01/10/2022
2	NDC:69981-704-02	60 mL in 1 JAR; Type 0: Not a Combination Product	01/10/2022
3	NDC:69981-704-04	120 mL in 1 JAR; Type 0: Not a Combination Product	01/10/2022
4	NDC:69981-704-08	240 mL in 1 JAR; Type 0: Not a Combination Product	01/10/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/10/2022

Labeler - Rev Pharma Corporation (079422405)

Revised: 12/2021

Document Id: d41f1c1a-7bd9-1723-e053-2a95a90a0d0a

Set id: 8f64b092-46b2-4ea7-b091-bc4a4e985a9c

Version: 1

Effective Time: 20211227

Rev Pharma Corporation