Primaguard
FDA Label NDC 75904-3343

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Choice Medical Supply for the product Primaguard (NDC 75904-3343). 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 active ingredient, purpose, uses, warnings: for external use only, otc - keep out of reach of children, directions, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lanolin USP 30%

Purpose

Skin Protectant

Uses

  • Helps prevent and treat skin irritations.
  • Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.

Warnings: For External Use Only

  • Avoid contact with eyes.
  • Do not apply to deep or puncture wounds.
  • If condition worsens, or does not improve within 7 days, consult a doctor.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

  • KEEP OUT OF REACH OF CHILDREN.

Directions

Gently cleanse and dry area. Apply liberally to affected area as needed.

Other Information

Store at 20-25°C (68-77°F)

Inactive Ingredients:

Beeswax (yellow wax), Disodium EDTA, Fragrance, Lanolin Alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate

Otc - Questions

Questions or comments?

Call 800-809-4556

or visit www.fcms

First Choice Medical Supply

127 Interstate Dr.

Richland, MS 39218

Images Of Representative Container Artwork

PrimaGuardProtectTubeLabel.jpg

Tube (Primaguardprotecttubelabel)

Tube (Primaguardprotecttubelabel)

* Please review the disclaimer below.