Label: OKEEFFES HEALTHY FEET PAIN RELIEF CREAM- pain relief cream lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    Allantoin 0.5%
    Lidocaine HCI 4%

  • PURPOSE

    Purposes
    Allantoin 0.5%  .........Skin protectant
    Lidocaine HCI4%  ....Topical analgesic

  • INDICATIONS & USAGE

    Uses temporarily
    • relieves pain and itching associated with minor
      skin irritations
    • protects and helps relieve chapped or cracked
      skin

  • WARNINGS

    Warnings
    For external use only

    Do not use
    • in large quantilies, particularly over raw
      surfaces or blistered areas.
    • on deep or puncture wounds, animal biles or
      serious burns

    When using this product avoid conlacl with eyes

    Stop use and ask a doctor if
    • condilion worsens
    • symploms last more Ihan 7days or clear up
      and occur again wilhin afew days

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a heallh
    professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed,
    get medical help or contact a Poison Control
    Center righl away.

  • DOSAGE & ADMINISTRATION

    Directions
    • adults and children 12 years of age and older:
       Apply to affected area not more than 3 to 4
       times daily.
    • children under 12 years of age: consult a doclor.

  • OTHER SAFETY INFORMATION

    Other information Child-resistant packaging.
    Store with lid closed tightly.

  • INACTIVE INGREDIENT

    Inactive ingredients Acrylates/C10-30 Alkyl
    Acrylate Crosspolymer, Aluminum Starch
    Octenylsuccinate, Beeswax, Caprylyl Glycol,
    Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol,
    Dimelhicone, Disodium EDTA, Ethylhexylglycerin,
    Glycerin, Glyceryl Stearate, 1,2 Hexanediol,
    Isopropyl Myrislate, Laureth-12, PEG-100
    Stearate, Peppermint (Mentha Piperita) Oil,
    Phenoxyethanol, Polysilicone-11, Shea
    (Butyrospermum Parkii) Butter, Sodium
    Hydroxide, Water, Xanthan Gum

  • Principal Display Package

    O'KEEFFE'S

    FOR HEALTHY FEET

    Net Wt. 3 oz. (85 g)

    Distributed by:

    O'Keeffe's Company, Cincinnati, OH 45241

    Questions/Comments: 1-800-275-2718

    Carton

    HlthyFt Carton

    Tube

    HlthyFt Tube

    res

  • INGREDIENTS AND APPEARANCE
    OKEEFFES HEALTHY FEET PAIN RELIEF CREAM 
    pain relief cream lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LAURETH-12 (UNII: OAH19558U1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0311-11 in 1 CARTON03/01/2022
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2022
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
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