Active Ingredient
Petrolatum 41%
Advanced Healing Ointment
FDA Label NDC 57337-193
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International Corp. for the product Advanced Healing (NDC 57337-193). 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
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 winds and cold weather
helps heal and prevent diaper rash
protects chapped skin associated with diaper rash and helps protect from wetness
Warnings
For external use only
When Using This Product
When using this product, do not get into eyes.
Stop Use And Ask A Doctor If
Stop use and ask a doctor if confition worsens, symptoms last more than 7 days or clear up and occur again with a few days.
Do Not Use On
Do not use on deep or puncture wounds, animal bites, serious burns
Keep Out Of Reach Of Children
if swallowed, get medical help r contact a Poison Control Center right away.
Directions
apply as needed
for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply ointment 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
Bisabolol
Glycerin
Panthenol
Label
Label (Label 193)
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Label (Label 193(2))
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