BABY PETROLATUM JELLY- petrolatum jelly
SHIELD LINE LLC

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.

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Active Ingredient

White Petrolatum USP (99.9% )

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash
helps seal out wetness

Warnings: FOR EXTERNAL USE ONLY

Do not use on

deep and punture 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 clean up and occur again in few days

Keep out of reach of children

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

Directions

apply liberally to clean out diaper rash area

Other Information

Store at room temperature

Inactive Ingredient

Fragrance

Package Label

BABY PETROLATUM JELLY
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52410-0206
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.9 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52410-0206-2	226 g in 1 JAR; Type 0: Not a Combination Product	06/21/2016
2	NDC:52410-0206-4	368 g in 1 JAR; Type 0: Not a Combination Product	06/21/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/21/2016

Labeler - SHIELD LINE LLC (078518916)