Skin Protectant Ointment
FDA Label NDC 11344-247

13 label sections · Submitted to the FDA by Nice-pak Products, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Skin Protectant (NDC 11344-247). 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, when using this product, stop use and ask a doctor if, do not use on, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Petrolatum 41%

Purpose

Skin protectant (ointment)

Uses

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

Warnings

For external use only

When Using This Product

  • do not get in 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

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep Out Of Reach Of Children.

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

Directions

  • apply as needed

Inactive Ingredients

minerol oil, ceresin, lanolin alcohol, panthenol, glycerin, bisabolol

Disclaimer

**This product is not manufactured or distributed by Beiersdorf Inc., distributor Aquaphor ® Healing Ointment.

Adverse Reactions

Distributed by: 

Nice-Pak Products, LLC

8800 Page Ave.

St. Louis, MO, 63114

Principal Display Panel

SIMPLY U  ®

ADVANCED HEALING OINTMENT

SKIN PROTECTANT

FRAGRANCE FREE

for dry, cracked or irritated skin

soothes and protects

Compare to Aquaphor  ®Healing Ointment*

NET WT 1.75 OZ (50 g)

Image Description (Mm02)

Image Description (Mm02)

SWAN ®

ADVANCED HEALING OINTMENT

skin protectant

  • Fragrance free
  • For dry, cracked or irritated skin
  • Soothes and protects

    • Compare to Aquaphor ®Healing Ointment*

    NET WT 1.75 OZ (50 g)

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.