CUREFINI SKIN PROTECTION CREAM- petrolatum cream 
Rev Pharma Corp

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 Skin Protection Cream

Drug Facts:

Active Ingredient:

Petrolatum 30.00%

Porpose:

Skin Protectant

Uses:

Warnings:

For external use only. •Avoid contact with eyes. •  If symptoms persist for more than seven days, discontinue use and consult a 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:

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?

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Package Labeling:30ml

Label

Package Labeling:60ml

Label2

Package Labeling:120ml

Label3

Package Labeling:240ml

Label4

CUREFINI SKIN PROTECTION CREAM 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69981-194
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM300 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CHAMOMILE (UNII: FGL3685T2X)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69981-194-0130 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
2NDC:69981-194-0260 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
3NDC:69981-194-04120 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
4NDC:69981-194-08240 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/12/2021
Labeler - Rev Pharma Corp (079422405)

Revised: 6/2021
Document Id: c5f870f7-c9a3-2844-e053-2a95a90a4207
Set id: 3c594493-5497-434b-9516-8a1f15f7866f
Version: 1
Effective Time: 20210630
 
Rev Pharma Corp