Label: OHEAL SHINGLES PAIN RELIEF CREAM- shingles pain relief cream cream

  • NDC Code(s): 83176-004-01
  • Packager: Dr.luke Healthcare LLC
  • 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 March 9, 2023

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  • Active Ingredient

    MENTHOL, UNSPECIFIED FORM 3%

  • Purpose

    Topical analgesic

  • Use

    For the treatment of symptomsof shingles, hives, and rashes.

  • Warnings

    For external use only.Avoid contact with eyes, flush with water immediately if it getsinto your eyes.Keep out of reach of children.

  • Do not use

    On broken skin
    On eyes area

  • WHEN USING SECTION

    For external use only.Avoid contact with eyes, flush with water immediately if it getsinto your eyes.Keep out of reach of children.

  • STOP USE section

    If you are allergic to this product.

  • Directions

    Apply to the affected areas 2-3 times daily.
    Children should use it under the supervision of adults.

  • Inactive ingredients

    Water, Mineral oil, Glycerin, Cetyl Alcohol, Aloevera Extract,Coconut Oil, Propylene Glycol, Artemisia Extract, K chiaSoparia seeds , Dictamni Cortex, Smilax Glabra Roxb.Solidago decurrens, Phellodendron amurense Ruprecht.Euphorbia Fischeriana Root,Gleditsia Sinensis, StemonaTuberosa,Equally extracted herbalextracts,Sophora flavescensVitamin E.

  • QUESTIONS

    www.ohealpro.com
    Info@ohealpro.com

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    83176-004-01

    83176-004-01

  • INGREDIENTS AND APPEARANCE
    OHEAL SHINGLES PAIN RELIEF CREAM 
    shingles pain relief cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEMONA TUBEROSA WHOLE (UNII: 9373ZOT316)  
    ALOE (UNII: V5VD430YW9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EUPHORBIA FISCHERIANA ROOT (UNII: R4DRG4762Y)  
    SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARTEMISIA PRINCEPS WHOLE (UNII: 2849G48V9J)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SOLIDAGO DECURRENS WHOLE (UNII: Y026RJV99T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)  
    SMILAX LANCEIFOLIA WHOLE (UNII: WBP9EYZ1XE)  
    PHELLODENDRON AMURENSE WHOLE (UNII: 3OZN5NGR9L)  
    GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)  
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83176-004-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/10/2023
    Labeler - Dr.luke Healthcare LLC (118868014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.luke Healthcare LLC118868014manufacture(83176-004)
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