PROLOGEL URGENT CARE- lidocaine and sodium bicarbonate lotion 
Nova Neura, LLC

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.

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ProloGel® Urgent Care

Drug Facts

Active Ingredients*Purpose
Lidocaine 4%Topical Analgesic
Sodium Bicarbonate 5%Skin Protectant

Uses

For relief from

Warnings

For external use only

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
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)

Revised: 9/2021
Document Id: 877d9d87-17eb-41c2-9ab5-d19cae9b88e8
Set id: 9fc71191-4fcd-4d7b-966c-878a1e28d6c1
Version: 2
Effective Time: 20210903
 
Nova Neura, LLC