FDA.reportPublic FDA data

ProloGel Pain Relief

Manufacturer
Nova Neura, LLC
Effective date
2021-09-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:16

Label at a glance#

ProductProloGel Pain Relief
Active ingredientCAMPHOR (SYNTHETIC), SODIUM BICARBONATE
Label structure7 sections

Indications and uses

For relief from minor pain aches & pains of sore muscles & joints associated with arthritis backache bruises strains & sprains.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

For relief from

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

Warnings

WARNINGS SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens

  • Irritation or redness develops.

Ask doctor before use

OTC - ASK DOCTOR SECTION

If you have sensitive skin.

Directions

DOSAGE & ADMINISTRATION SECTION

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*

INACTIVE INGREDIENT SECTION

Behenyl alcohol, Butyrospermum Parkii, 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

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ProloGel®

PAIN RELIEF
FORMULA

Clinical Strength
Deep Penetrating
Vanishing Odor

Topical Therapeutic Lotion

Net Wt. 5 oz / 148 mL

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77496-101-112023-01-30C16284748780-1f386c649-a029-0266-e053-dadaa90a7c1aProloGel ® Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77496-101-11ProloGel Pain Relief148 mL in 1 BOTTLE, PUMPLOTION1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77496-101PROLOGEL PAIN RELIEF (CAMPHOR (SYNTHETIC) AND SODIUM BICARBONATE) LOTION [NOVA NEURA, LLC]2Legacy NDC, 1 package rows20210905_a1741cbb-37a6-485d-9d62-5e096ddffa0e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77496-10177496-101-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB
DOCOSANOL9G1OE216XYIACT
SHEA BUTTERK49155WL9YIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GUAR GUME89I1637KEIACT
MANNITOL3OWL53L36AIACT
OLEYL ALCOHOL172F2WN8DVIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
CASTOR OILD5340Y2I9GIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ff163568-addd-41b7-b99d-22fa5dff2f7ba1741cbb-37a6-485d-9d62-5e096ddffa0e2021-09-03WarningsExact identifier
spl id: ff163568-addd-41b7-b99d-22fa5dff2f7b
spl set id: a1741cbb-37a6-485d-9d62-5e096ddffa0e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.