Active Ingredient
Petrolatum 41%
Leader Baby Skin Protectant Ointment
FDA Label NDC 70000-0079
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Baby Skin Protectant (NDC 70000-0079). 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 us and ask a doctor if, do not use, 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
- Helps treat and prevent diaper rash
- Protects chafed skin associated with diaper rash and helps protect from wetness
- Temporarily protects minor cuts, scrapes,and burns
- Temporarily protects and helps relieve chapped, or cracked skin and lips
- Helps protect skin from the drying effects of wind and cold weather
Warnings
For external use only
When Using This Product
do not get in the eyes
Stop Us 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 puncture wounds
- Animal bites
- Serious burns
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.
Directions
- Apply as needed or as directed by a physician
- For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area and 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.
Other Information
- Store at room temperature between 15°-30°C (59°-86°F)
- Do not use if safety seal is broken or missing
Inactive Ingredients
Ceresin, Dexpanthenol, Glycerin, Lanolin Alcohols, Mineral Oil
Questions And Comments?
1-888-396-2739
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