PETROLEUM JELLY WITH LAVENDER AND VANILLA- petrolatum jelly
Delon Laboratories (1990) 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 Ingredient

White Petrolatum USP (99.8%)

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 wind and cold weather

Directions

Apply as needed.

Warnings

For external use only.
When using this product do not get into eyes.
See a doctor if condition lasts more than 7 days.
Do not use on deep or puncture wounds, animal bites, serious burns.

Purpose

Skin protectant.

INACTIVE INGREDIENTS

Inactive Ingredients: Parfum (Fragrance), Lavandula Angustifolia (Lavender) Oil, Vanilla Planifolia Fruit Extract.

Keep out of reach of children

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

PJ Lavender Vanilla

PETROLEUM JELLY WITH LAVENDER AND VANILLA
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61734-412
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.1 g in 100 g
VANILLA (UNII: Q74T35078H)	0.05 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61734-412-01	368 g in 1 JAR; Type 0: Not a Combination Product	09/02/2014	12/03/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/02/2014	12/03/2014

Labeler - Delon Laboratories (1990) Ltd (248364184)

Name	Address	ID/FEI	Business Operations
Establishment
Delon Laboratories (1990) Ltd		243387722	label(61734-412) , manufacture(61734-412) , pack(61734-412)

Revised: 9/2016

Document Id: 3cf11fb4-ca1b-2b57-e054-00144ff8d46c

Set id: 3d90d0a8-4500-400b-ba95-203b7ab5dad0

Version: 3

Effective Time: 20160920

Delon Laboratories (1990) Ltd