WHITE PETROLATUM- petrolatum ointment 
STRATUS PHARMACEUTICALS INC

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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WHITE PETROLATUM

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.

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

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

PRINCIPAL DISPLAY PANEL - 5 g Packet Box
WHITE PETROLATUM 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM5 [USP'U]  in 5 g
Product Characteristics
ColorWHITE (OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-350-50144 in 1 BOX07/12/2019
15 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34707/12/2019
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIBusiness Operations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-350)

Revised: 11/2022
Document Id: eec7129d-a680-4233-acef-e8db8c490da2
Set id: c8c1b96e-cc12-495f-a027-8c7c9bcda374
Version: 3
Effective Time: 20221104
 
STRATUS PHARMACEUTICALS INC