Label: WHITE PETROLATUM- petrolatum ointment

  • NDC Code(s): 58980-350-50
  • Packager: STRATUS PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 4, 2022

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  • 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

    PRINCIPAL DISPLAY PANEL - 5 g Packet Box
  • INGREDIENTS AND APPEARANCE
    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)
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