Prologel Pain Relief
FDA Label NDC 77496-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nova Neura, Llc for the product Prologel Pain Relief (NDC 77496-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, if pregnant or breast-feeding, keep out of reach of children, stop use and ask a doctor if, ask doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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, Puriļ¬ed water, Ricinus Communis (Castor) Seed Oil, Sodium hydroxide, Sorbitan stearate.

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

Principal Display Panel (148 mL Bottle Label)

Principal Display Panel (148 mL Bottle Label)

* Please review the disclaimer below.