Label: MEDICATED LIP BALM salve
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-6040-01, 0363-6040-02 - Packager: Walgreen Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 15, 2013
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDICATED LIP BALM
medicated lip balm salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 1.7 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.7 mg in 1 g PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 0.4 mg in 1 g Inactive Ingredients Ingredient Name Strength ALUM, POTASSIUM (UNII: 1L24V9R23S) WHITE WAX (UNII: 7G1J5DA97F) COCOA BUTTER (UNII: 512OYT1CRR) LANOLIN (UNII: 7EV65EAW6H) PETROLATUM (UNII: 4T6H12BN9U) SALICYLIC ACID (UNII: O414PZ4LPZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-6040-02 2 in 1 BLISTER PACK 1 NDC:0363-6040-01 7 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/30/2013 Labeler - Walgreen Co (008965063) Registrant - Lee Pharmaceuticals (056425432) Establishment Name Address ID/FEI Business Operations Lee Pharmaceuticals 056425432 manufacture(0363-6040)