PURE PETROLATUM- petrolatum jelly

Drug Labeling and Warnings

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Amoray Petroleum Jelly

Active Ingredient

White Petrolatum (100% w/w)

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

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

WARNINGS

Warnings:

For external use only

When using this product

• do not get into 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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

• apply as needed

INACTIVE INGREDIENT

Inactive Ingredient

none

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE PETROLATUM 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51628-5600
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51628-5600-1	170 g in 1 JAR; Type 0: Not a Combination Product	04/18/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/18/2026

Labeler - MY IMPORTS USA LLC (195767988)

Registrant - VASA COSMETICS PRIVATE LIMITED (955446947)

Establishment
Name	Address	ID/FEI	Business Operations
VASA COSMETICS PRIVATE LIMITED		955446947	manufacture(51628-5600)