ProloGel Urgent Care: Package Insert and Label Information

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.

Drug Facts

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
(click image for full-size original)
PROLOGEL URGENT CARE
lidocaine and sodium bicarbonate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77496-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 0.04 mg in 1 mL
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 0.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DOCOSANOL
SHEA BUTTER
ORANGE OIL, COLD PRESSED
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
GUAR GUM
MANNITOL
OLEYL ALCOHOL
POLYSORBATE 20
WATER
CASTOR OIL
SODIUM HYDROXIDE
SORBITAN MONOSTEARATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77496-102-11 148 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 12/01/2020
Labeler — Nova Neura, LLC (117121636)

Revised: 09/2021 Nova Neura, LLC

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