Skin Protectant Ointment
FDA Label NDC 41190-180

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wakefern Food Corp. for the product Skin Protectant (NDC 41190-180). 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, 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.

Label Section Quick Index

Active Ingredient

Petrolatum 41%

Purpose

Skin protectant

Uses

  • temporarily protects minor: cuts, scrapes, burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps protect from the drying effects of wind and cold weather
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

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 contact a Poison Control Center right away.

Directions

  • apply as needed
  • for diaper rash, change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive Ingredients

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

Disclaimer

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Baby Aquaphor ®Advanced Therapy Healing Ointment

Adverse Reaction

Distributed By: Wakefern Food Corp. 5000 Riverside Drive

Keasbey, NJ 08832   ©2024

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We welcome your questions and comments.

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Compare to Baby Aquaphor ® Advanced Therapy Healing Ointment*

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Baby Healing Ointment

SKIN PROTECTANT

For dry, chapped or irritated skin

Hypoallergenic

NET WT 3 OZ (85 g)

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