Label: DIAPER RASH- zinc oxide paste

  • 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 March 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 40%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only.

    Avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

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

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, BHA, cetyl alcohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Perrigo Direct, Inc.
    Peachtree City, GA 30269

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

    GOODSENSE®
    NDC 50804-079-01

    Maximum Strength

    Diaper Rash Paste

    40% Zinc Oxide

    Soothes Burning
    Prevents Diaper Rash
    Protects Skin

    NET WT 2 oz (56.7 g)

    Compare to active ingredients of
    Desitin® Maximum Strength*

    Principal Display Panel - 56.7 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    DIAPER RASH 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
    Lanolin (UNII: 7EV65EAW6H)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Water (UNII: 059QF0KO0R)  
    Shea Butter (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-079-011 in 1 CARTON05/29/2020
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/29/2020
    Labeler - GOODSENSE (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(50804-079)
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