Label: PREFERRED PLUS MEDICATED LIP BALM- medicated lip balm stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 28, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    • Camphor, 1.7%
    • Menthol, 0.7%
    • Phenol, 0.4%
  • Purpose

    • Anti-infective
    • Anti-itching
    • Anesthetic
  • Uses

    • Temporarily relieves pain and itching commonly associated with fever blisters and cold sores.
    • Helps prevent dry, chapped, sun and wind burned lips.
  • Warnings

    • For external use only
    • Keep out of eyes
  • STOP USE

    • Stop if skin rash occurs
    • If irritation or rash persists, consult a physician
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    • Apply generously as needed
    • Children under 6 months of age:  Consult a doctor
  • INACTIVE INGREDIENT

    Alum, Beeswax, Cocoa Butter, Flavor, Lanolin, Petrolatum, Salicylic Acid

  • PRINCIPAL DISPLAY PANEL

    Preferred Plus

    Lip Balm Medicated

    card image

    image of card

  • PRINCIPAL DISPLAY PANEL

    Preferred Plus

    Lip Balm Medicated

    label image

    image of label

  • INGREDIENTS AND APPEARANCE
    PREFERRED PLUS MEDICATED LIP BALM 
    medicated lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)17 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUM, POTASSIUM (UNII: 1L24V9R23S)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-051-942 in 1 BLISTER PACK
    1NDC:61715-051-934.25 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/28/2007
    Labeler - Kinray (012574513)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kinray012574513label(61715-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432manufacture(61715-051) , pack(61715-051)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!