Theraplex
FDA Label NDC 62917-065

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Theraplex Company, Llc for the product Theraplex (NDC 62917-065). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Petrolatum (65%)

Purpose

Skin Protectant

Uses

• temporarily protects and helps relieve chapped or cracked skin and lips • helps protect from the drying effects of wind and cold weather • temporarily protects minor: • cuts • scrapes • burns

Warnings

Warnings For external use only

When using this product do not get into eyes.

Stop and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on • deep or puncture wounds • animal bites • serious burns

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions apply as needed, or as directed by your doctor.

Storage And Handling

Other information • store at room temperature • keep from freezing

Inactive Ingredient

Inactive Ingredients cyclomethicone, microcrystalline wax

Otc - Questions

Questions? call 1-888-437-2753

Other

Clinically-proven Theraplex Healing Emollient combines a unique enriched special petrolatum fraction (ESPF) with a novel hydrosilicone delivery system that deeply penetrates severely dry skin. Dermatologists have recommended this healing formulation for years because of its ability to deliver soothing moisturization and long-lasting skin barrier protection with no irritation to sensitive, compromised skin.

  • Noncomedogenic (Won't Clog Pores)
  • Hypoallergenic
  • Preservative-Free
  • Fragrance-Free
  • Paraben-Free
  • Gluten-Free

    • Skin Protectant • For Severely Dry & Sensitive Skin
    Dermatologist recommended for adults & children

    Distributed by:
    The Theraplex Company, LLC
    Memphis, TN 38119
    www.theraplex.com

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