Label: PINXAV DAIPER RASH- zinc oxide ointment

  • NDC Code(s): 82778-342-04, 82778-342-16
  • Packager: Emjay Laboratories 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 May 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 30%

  • Purpose

    Skin Protectant

  • Uses

    • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac.
  • Warnings

    For external use only

    When using this product, avoid contact with the eyes

    Stop use and ask a doctor if condition worsens or does not improve within 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

    For diaper rash:

    • change wet or soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Inactive ingredients

    Aloe Vera Gel, Aluminum Hydroxide, Cetyl Alcohol, Clove Leaf Oil, Eucayptol, Lanolin, Menthol, Methyl Salicylate, Petrolatum, Red Ferric Oxide, Stearic Acid, Tocopherol

  • Questions or comments?

    Call 1-888-4-PINXAV or visit us at www.pinxav.com 

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

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Jar Label

    PINXAV NDC 
    SKIN PROTECTANT


    • helping to Soothe ,Heal and prevent Diaper rash 

    Net Wt 16 OZ (454 g)

    Principal Display Panel – Jar Label

  • Principal Display Panel - 4.0 OZ Tube

    PINXAV  DIAPER RASH Ointment 

    Skin protectant Zinc Oxide 30%

    Help Soothe & Protect Chafed Skin

    NET WT 4.0 OZ (113.4g)

    Principal Display Panel - 4.0 OZ Tube

  • Principal Display Panel - 4.0 OZ Carton

    PINXAV DIAPER RASH Ointment 

    Skin protectant Zinc Oxide 30%

    Help Soothe & Protect Chafed Skin

    NET WT 4.0 OZ (113.4 g)

    Principal Display Panel - 4.0 OZ Carton

  • INGREDIENTS AND APPEARANCE
    PINXAV DAIPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82778-342
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82778-342-041 in 1 CARTON03/30/2004
    1113.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:82778-342-16454 g in 1 JAR; Type 0: Not a Combination Product03/30/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/30/2004
    Labeler - Emjay Laboratories Inc. (152870056)
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