Label: LIP RECOVERY- petrolatum ointment

  • NDC Code(s): 67879-307-11, 67879-307-51
  • Packager: PHARMAGEL INTERNATIONAL INC
  • 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 October 27, 2021

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  • ACTIVE INGREDIENTS

    PETROLATUM............................48%

  • PURPOSE

    LIP PROTECTANT

  • USES

    • HELPS PROTECT, RELIEVE, AND PREVENT CHAPPED LIPS
    • HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER

  • WARNINGS

    WHEN USING THIS PRODUCT

    • DO NOT GET INTO EYES.
    • AVOID CONTACT WITH THE EYES. IF PRODUCT GETS INTO THE EYES, RINSE THOROUGHLY WITH WATER.
  • STOP USE AND ASK DOCTOR

    IF IRRITATION OR RASH DEFELOPS AND CONTINUES FOR MORE THAN 72 HOURS.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions:

    • Apply daily to lips. Reapply as needed.

  • INACTIVE INGREDIENTS:

    HYDROGENATED POLYISOBUTENE, TRIACONTANYL PVP, BUTYROSPERMUM PARKII BUTTER, PARAFFIN, SILICA, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, ISOHEXA- DECANE, CYCLOPENTASILOXANE, TOCOPHEROL, SODIUM HYALURONATE, TRIPEPTIDE-1, TETRAHEXYLDECYL ASCOR- BATE, RETINYL PALMITATE, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE, ETHYLHEXYL METHOXYCINNAMATE, BENZO- PHENONE-3, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, BIS-PEG/PPG-14/14 DIMETHICONE, XANTHAN GUM, BHT, BENZYL ALCOHOL,PHENOXYETHANOL

  • Questions or Comments?

    Call 800.882.1889

  • PRINCIPAL DISPLAY PANEL

    LR_RL-1_box_2.jpg

  • INGREDIENTS AND APPEARANCE
    LIP RECOVERY 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67879-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM48 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLENE (UNII: 91GW059KN7)  
    PROPYLENE (UNII: AUG1H506LY)  
    STYRENE (UNII: 44LJ2U959V)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PREZATIDE (UNII: 39TG2H631E)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DEANOL BITARTRATE (UNII: D240J05W14)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    1-BUTENE (UNII: LY001N554L)  
    BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67879-307-511 in 1 BOX06/13/2016
    1NDC:67879-307-1115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/18/2015
    Labeler - PHARMAGEL INTERNATIONAL INC (603215182)
    Registrant - PHARMAGEL INTERNATIONAL INC (603215182)
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