PETROLEUM ORIGINAL- white petrolatum jelly
Ningbo Liyuan Daily Chemical Products Co., Ltd.

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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Drug Facts
Active Ingredients

White Petrolatum USP 100 percent

Purpose

skin protectant

USE:

Helps treat and prevent diaper rash. Helps seal out wetness.

Warnings:

For external use only.

Do not apply over deep puncture wounds, infections, or lacerations.

If redness or swelling develops, consult a physician promptly.

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally, as often as necessary.

label

PETROLEUM ORIGINAL
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76176-065
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76176-065-01	170 g in 1 JAR; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/01/2020

Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)

Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(76176-065)

Revised: 8/2020

Document Id: adb109f6-7ca6-80d7-e053-2a95a90ae3b9

Set id: adb10ad9-a052-2ece-e053-2995a90a88c6

Version: 1

Effective Time: 20200801