PROLOGEL PAIN RELIEF (camphor- synthetic and sodium bicarbonate lotion

ProloGel Pain Relief by

Drug Labeling and Warnings

ProloGel Pain Relief by is a Otc medication manufactured, distributed, or labeled by Nova Neura, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, 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

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

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

ProloGel®

PAIN RELIEF
FORMULA

Clinical Strength
Deep Penetrating
Vanishing Odor

Topical Therapeutic Lotion

Net Wt. 5 oz / 148 mL

INGREDIENTS AND APPEARANCE

PROLOGEL PAIN RELIEF 
camphor (synthetic) and sodium bicarbonate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77496-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 BICARBONATE	0.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77496-101-11	148 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/2020

Labeler - Nova Neura, LLC (117121636)