Welmedix Homecare Pro Fragile Skin Protectant Ointment
FDA Label NDC 24330-413

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Welmedix Llc for the product Welmedix Homecare Pro Fragile Skin Protectant (NDC 24330-413). 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 ingredients, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Petrolatum 42%

Purpose

Skin Protectant

Uses

  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
  • helps treat and prevent diaper rash
  • protects chafed skin associated with diaper rash and helps protect from wetness
  • temporarily protects: • minor cuts • scrapes • burns

Warnings

For external use only

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

When using this product do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

If swallowed, get medical help or consult a Poison Control Center right away.

Directions:

For general skin protection: apply as needed.

For incontinence care: change wet and soiled diapers and garments promptly. • Cleanse the affected area and allow to dry. • Apply ointment liberally, as often as necessary, especially at bedtime or any time when exposure to wet, moist or soiled garments may be prolonged.

Other Information:

Store at 20-25° C (68-77° F)

Inactive Ingredients

water, helianthus annuus (sunflower) seed oil, lanolin alcohol, dimethicone, glycerin, sorbitan sesquioleate, glyceryl stearate, hydrogenated coconut oil, lanolin, phenoxyethanol, stearyl alcohol, aloe barbadensis leaf juice, cetyl alcohol, calendula officinales flower extract, glycine soja (soybean) oil, ceresin, mineral oil

Principal Display Panel

Welmedix ®

HomeCare
PRO

Fragile Skin
Protective Ointment

PROTECTS + NOURISHES

PETROLATUM 42%

SKIN PROTECTANT

Net Wt 12 oz (340g)

Jar Label (Wmdx Po Jar V8 1)

Jar Label (Wmdx Po Jar V8 1)

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