Label: LIP REMEDY MEDICINAL LIP BALM- petrolatum stick
LIP REMEDY MEDICINAL LIP BALM- petrolatum stick
LIP REMEDY MEDICINAL LIP BALM- petrolatum stick
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Contains inactivated NDC Code(s)
NDC Code(s): 75862-012-50, 75862-013-50, 75862-014-50 - Packager: GANZ U.S.A., LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 16, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 4 g Blue Carton
- PRINCIPAL DISPLAY PANEL - 4 g Green Carton
- PRINCIPAL DISPLAY PANEL - 4 g Red Carton
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INGREDIENTS AND APPEARANCE
LIP REMEDY MEDICINAL LIP BALM BLUE
petrolatum stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75862-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 32.3 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) CERESIN (UNII: Q1LS2UJO3A) CANDELILLA WAX (UNII: WL0328HX19) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) COCOA BUTTER (UNII: 512OYT1CRR) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) MENTHOL (UNII: L7T10EIP3A) PHENOL (UNII: 339NCG44TV) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) D&C RED NO. 6 (UNII: 481744AI4O) ALUMINUM OXIDE (UNII: LMI26O6933) SACCHARIN (UNII: FST467XS7D) Product Characteristics Color YELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75862-012-50 1 in 1 BOX 1 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 02/01/2011 LIP REMEDY MEDICINAL LIP BALM GREEN
petrolatum stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75862-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 32.3 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) CERESIN (UNII: Q1LS2UJO3A) CANDELILLA WAX (UNII: WL0328HX19) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) COCOA BUTTER (UNII: 512OYT1CRR) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) MENTHOL (UNII: L7T10EIP3A) PHENOL (UNII: 339NCG44TV) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) D&C RED NO. 6 (UNII: 481744AI4O) ALUMINUM OXIDE (UNII: LMI26O6933) SACCHARIN (UNII: FST467XS7D) Product Characteristics Color YELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75862-013-50 1 in 1 BOX 1 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 02/01/2011 LIP REMEDY MEDICINAL LIP BALM RED
petrolatum stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75862-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 32.3 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) CERESIN (UNII: Q1LS2UJO3A) CANDELILLA WAX (UNII: WL0328HX19) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) COCOA BUTTER (UNII: 512OYT1CRR) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) MENTHOL (UNII: L7T10EIP3A) PHENOL (UNII: 339NCG44TV) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) D&C RED NO. 6 (UNII: 481744AI4O) ALUMINUM OXIDE (UNII: LMI26O6933) SACCHARIN (UNII: FST467XS7D) Product Characteristics Color YELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75862-014-50 1 in 1 BOX 1 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 02/01/2011 Labeler - GANZ U.S.A., LLC (798785242)