Label: CUREFINI - petrolatum and cod liver oil ointment
- NDC Code(s): 65121-712-65
- Packager: Pure Source
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 for cuts & burns SKIN PROTECTION OINTMENT
- Active Ingredients
- Petrolatum 30.00%
- Cod Liver Oil 10.00%
- Use For:
- Temporarily protects minor cuts, scrapes and burns.
- Temporarily protects chapped or cracked skin.
- Helps protect from drying effects of wind and cold weather.
- For external use only
- When using this product, do not get into eyes
- If conditions 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.
- STORAGE AND HANDLING
Store at room temperature.Close
- Apply as needed. Prepare a gauze bandage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with 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.
- Other Ingredients:
beeswax, BHT, Sunflower oil, Sweet almond oilClose
- CUREFINI 8oz/240ml (65121-712-65)
- INGREDIENTS AND APPEARANCE
petrolatum, cod liver oil ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65121-712 Route of Administration TOPICAL DEA Schedule 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 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 (969241041) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(65121-712)