PROLOGEL NEUROTHERAPY- camphor (synthetic) 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® Neurotherapy

Drug Facts

Active Ingredients*Purpose
Camphor 0.1%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:

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
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)

Revised: 9/2021
Document Id: 72b5dc5d-d65a-4046-855c-cec4d7e93aaf
Set id: 658cd1a9-71a6-45b6-b9fb-22b668f9973c
Version: 2
Effective Time: 20210903
 
Nova Neura, LLC