Leader Baby Skin Protectant: Package Insert and Label Information

LEADER BABY SKIN PROTECTANT- petrolatum ointment
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Petrolatum 41%

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 15º-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

Label

CR-5684378 IN MASTER
(click image for full-size original)

LEADER BABY SKIN PROTECTANT
baby skin protectant ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0079
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 41 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
DEXPANTHENOL
LANOLIN ALCOHOLS
MINERAL OIL
CERESIN
Product Characteristics
Color Score
Shape FREEFORM Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0079-1 85 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 02/08/2021
Labeler — Cardinal Health (063997360)

Revised: 06/2021 Cardinal Health

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.