Label: OKEEFFES WORKING HANDS PAIN RELIEF SKIN PROTECTANT- allantoin, lidocaine hydrochloride cream

  • NDC Code(s): 71564-009-03
  • Packager: The Gorilla Glue Company/O'Keeffe's Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients . . . . . . . . . . . . . Purposes

    Allantoin 0.5% . . . . . . . . . . . . . . . . Skin protectant

    Lidocaine HCl 4% . . . . . . . . . . . . . Topical analgesic

  • PURPOSE

    Purposes

  • Uses

    temporarily

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

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas.
    • on deep or puncture wounds, animal bites or serious burns

    When using this product avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

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

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

  • 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 doctor.
  • Other information

    Child-resistant packaging. Store with lid closed tightly.

  • Inactive ingredients

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

  • Questions or comments?

    1-800-275-2718

  • SPL UNCLASSIFIED SECTION

    O'KEEFFE'S ® WORKING HANDS ®

    PAIN RELIEF CREAM SKIN PROTECTANT

    PAIN RELIEF

    RELIEVES, SOOTHES & HYDRATES

    INSTANT RELIEF from:

    Pain

    Itching Irritation

    Dryness

    2 IN 1 PAIN RELIEF & MOISTURIZER

    MAX STRENGTH † 4% LIDOCAINE

    COOLING PEPPERMINT OIL

    CLINICALLY PROVEN

    RELIEVES

    SOOTHES

    HYDRATES

    PROTECTS

  • PRINCIPAL DISPLAY PANEL

    OKEEFFE'S ® WORKING HANDS ®

    PAIN RELIEF CREAM SKIN PROTECTANT

    Net Wt. 3 oz (85 g)

    OKeeffesCompany.com

    1-800-275-2718

    ©2023 Distributed by:

    O'Keeffe's Company

    Cincinnati, OH 45241

    Made in USA with Domestic and Imported Materials

    label

  • INGREDIENTS AND APPEARANCE
    OKEEFFES WORKING HANDS PAIN RELIEF  SKIN PROTECTANT
    allantoin, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71564-009
    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) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    LAURETH-12 (UNII: OAH19558U1)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71564-009-031 in 1 CARTON10/07/2023
    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 DrugM01710/07/2023
    Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)
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