Label: PROLOGEL URGENT CARE- lidocaine and sodium bicarbonate lotion

  • Category: HUMAN OTC DRUG LABEL

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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients*Purpose
    Lidocaine 4%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:

    • Use gloves (or skin barrier) with each application to prevent absorption into hands.
    • 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, Citrus Sinensis Peel Oil, Dimethicone, Disodium ETDA, Emulsfying wax NF, Glycerin, Guar gum, Mannitol, Oleyl alcohol, Polysorbate 20, Purified water, Ricinus Communis (Castor) Seed Oil, Sodium hydroxide, Sorbitan stearate.

  • Questions or Comments

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

  • PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

    ProloGel®

    URGENT CARE
    FORMULA

    For Rapid Relief
    Deep Penetrating
    Vanishing Odor

    Topical Therapeutic Lotion

    Net Wt. 5 oz / 148 mL

    PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PROLOGEL URGENT CARE 
    lidocaine and sodium bicarbonate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77496-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 mg  in 1 mL
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCOSANOL (UNII: 9G1OE216XY)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77496-102-11148 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 finalpart34812/01/2020
    Labeler - Nova Neura, LLC (117121636)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!