PETROLATUM JELLY- petrolatum jelly
ASTONEA LABS PRIVATE LIMITED

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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ASTONEA 99.9%

Active Ingredient

White Petrolatum (99.9% w/w)

Purpose

Skin Protectant

Uses

temporarily protects minor cuts, scrapes, burns and sunburn
temporarily protects and helps relieve chapped or cracked skin
helps protect from drying effect of wind and cold weather
helps treat and prevent diaper rash
help seal out wetness

Warnings

FOR EXTERNAL USE ONLY

When using this product

do not get into the eyes

Stop use and ask a doctor if

condition worsens
symptoms last for more than 7 days or clean up and occur again in a few days

Do not use on

deep or puncture wounds
animal bites
serious burns

Keep out of reach of children

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

Directions

apply as needed

Inactive Ingredient

Fragrance

Package Label

Principal Display and Drug Fact Panel

PETROLATUM JELLY
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77338-101
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:77338-101-03	226 g in 1 JAR; Type 0: Not a Combination Product	01/01/2023
2	NDC:77338-101-05	368 g in 1 JAR; Type 0: Not a Combination Product	01/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/11/2016

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)