ROYAL PETROLEUM JELLY- petrolatum jelly
Royal Exports

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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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

None

Package Label principal Display Label

ROYAL PETROLEUM JELLY
petrolatum jelly

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/10/2016

Labeler - Royal Exports (650621381)