FDA Label for Prologel Pain Relief

View Indications, Usage & Precautions

Prologel Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Nova Neura, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



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 [email protected]


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


* Please review the disclaimer below.