PETROLEUM- petrolatum jelly

PETROLEUM by

Drug Labeling and Warnings

PETROLEUM by is a Otc medication manufactured, distributed, or labeled by PRIMAL ELEMENTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

White Petrolatum (100%)

Purpose

Skin protectant

Use

• Helps treat and prevent diaper rash
• Petroleum jelly restores smooth and healthy skin
• Helps to soothe dry, chapped, cracked or irritated skin and lips due to cold and wind
• For the temporary protection of minor cuts, scrapes, burns and sunburn

Warnings:

For external use only

Avoid contact with eyes.

Stop use and ask a doctor if

condition worsens or does not improve after 7 days.

Keep out of reach of children

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

Directions

Apply liberally, as often as necessary.

Inactive

fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PETROLEUM 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80801-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80801-104-01	170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/01/2023

Labeler - PRIMAL ELEMENTS (968334144)