PETROLATUM JELLY- petrolatum jelly

Petrolatum Jelly by

Drug Labeling and Warnings

Petrolatum Jelly by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

White Petrolatum (99.6% 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

INGREDIENTS AND APPEARANCE

PETROLATUM JELLY 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.6 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-162-01	100 g in 1 JAR; Type 0: Not a Combination Product	01/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/11/2016

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Establishment
Name	Address	ID/FEI	Business Operations
ASTONEA LABS PRIVATE LIMITED		878533295	manufacture(77338-162)