ROYAL PETROLEUM JELLY- petrolatum jelly

Royal Petroleum Jelly by

Drug Labeling and Warnings

Royal Petroleum Jelly by is a Otc medication manufactured, distributed, or labeled by Royal Exports. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

White petrolatum (100 % 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 the drying effects of wind and cold weather
• helps treat and prevent diaper rash
• helps seal out wetness

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 more than 7 days or clear up and occur again within 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

None

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYAL PETROLEUM JELLY 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51328-1010
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51328-1010-3	226 g in 1 JAR; Type 0: Not a Combination Product	10/10/2016
2	NDC: 51328-1010-5	368 g in 1 JAR; Type 0: Not a Combination Product	10/10/2016
3	NDC: 51328-1010-4	283 g in 1 JAR; Type 0: Not a Combination Product	10/10/2016

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

Labeler - Royal Exports (650621381)