Label: PROLOGEL NEUROTHERAPY (camphor- synthetic and sodium bicarbonate lotion

  • 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 September 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients*Purpose
    Camphor 0.1%Topical Analgesic
    Sodium Bicarbonate 5%Skin Protectant
  • Uses

    For relief from

    • minor pain
    • aches & pains of sore muscles & joints associated with
    • arthritis
    • backache
    • bruises
    • strains & sprains.
  • Warnings

    For external use only

    • Use only as directed
    • Avoid contact with eyes and mucous membranes.
    • Do not apply to open wounds or damaged skin.
    • Store in cool dry place away from direct sunlight.

    If pregnant or breast-feeding

    Ask a health professional before use.

    Keep out of reach of children

    If accidentally ingested, get medical help or contact Poison Control Center immediately.

    Stop use and ask a doctor if

    Condition worsens

    • Irritation or redness develops.

    Ask doctor before use

    If you have sensitive skin.

  • Directions

    Shake well before each use. Keep cap on between uses.

    Adults and children 12 years of age or older:

    • Apply generous amount to clean, unbroken skin.
    • Allow lotion to rest on skin for approximately one minute
    • Rub lotion into the target area.
    • Reapply up to four times per day.
    • Wash hands thoroughly after each application.
  • Inactive Ingredients*

    Behenyl alcohol, Benfotiamine, Butyrospermum Parkii, Citrus Sinensis Peel Oil, Dimethicone, Disodium ETDA, Emulsfying wax NF, Glycerin, Guar gum, Mannitol, Oleyl alcohol, Polysorbate 20, Pterocarpus Marsupium Bark Extract, Purified water, Ricinus Communis (Castor) Seed Oil, Sodium hydroxide, Sorbitan stearate, Vitamin D.

  • Questions or Comments

    1 866-516-5508 or Support@ProloGel.com

  • PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

    ProloGel®

    NEUROTHERAPY
    FORMULA

    For Soothing Relief
    Deep Penetrating
    Vanishing Odor

    Topical Therapeutic Lotion

    Net Wt. 5 oz / 148 mL

    PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROLOGEL NEUROTHERAPY 
    camphor (synthetic) and sodium bicarbonate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77496-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.001 mg  in 1 mL
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENFOTIAMINE (UNII: Y92OUS2H9B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAR GUM (UNII: E89I1637KE)  
    MANNITOL (UNII: 3OWL53L36A)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PTEROCARPUS MARSUPIUM WHOLE (UNII: 398N0W54U6)  
    WATER (UNII: 059QF0KO0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77496-103-11148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/01/2020
    Labeler - Nova Neura, LLC (117121636)
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