WHITE PETROLATUM- petrolatum ointment

WHITE PETROLATUM by

Drug Labeling and Warnings

WHITE PETROLATUM by is a Otc medication manufactured, distributed, or labeled by STRATUS PHARMACEUTICALS INC, TARMAC PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredient

White Petrolatum USP 100%

Purpose

Skin Protectant

Indications

For the temporary protection of minor cuts, scrapes, abrasions, burns, sunburns, chafed or chapped skin. Helps treat and prevent diaper rash.

Caution

In case of deep or puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or if infection occurs, discontinue use and consult a physician.

For external use only.

Warnings

Do not use in the eyes.

If swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions

Cleanse area with mild soap and water.

Apply White Petrolatum liberally generously to affected area.

Other Information

Store at room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat.

Description

White Petrolatum USP is a first aid ointment that protects and revitalizes chapped and cracked skin areas. It contains 100% White Petrolatum USP to help seal moisture into the skin. White Petrolatum USP Ointment can be applied to minor skin injuries including cuts, scrapes, rashes and burns. Each pouch contains a 5g unit dose individually sealed and barcoded.

SPL UNCLASSIFIED SECTION

Distributed by: Stratus Pharmaceuticals Inc., Miami, FL 33186

QUESTIONS

Toll Free: 1-800-442-7882

PRINCIPAL DISPLAY PANEL - 5 g Packet Box

NDC: 58980-350-50

White Petrolatum USP
Ointment

Skin Protectant
Smooths skin irritations due to:
▪ minor burns   ▪ scrapes   ▪ abrasions

STRATUS
PHARMACEUTICALS INC

Contains:
144 packets / 5g each

INGREDIENTS AND APPEARANCE

WHITE PETROLATUM 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	5 [USP'U]  in 5 g

Product Characteristics
Color	WHITE (OFF WHITE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58980-350-50	144 in 1 BOX	07/12/2019
1		5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	07/12/2019

Labeler - STRATUS PHARMACEUTICALS INC (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
TARMAC PRODUCTS INC		059890491	MANUFACTURE(58980-350) , LABEL(58980-350) , PACK(58980-350)