Label: DIAPERENE CHILDREN- zinc oxide cream

  • 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 24, 2021

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide (13%)

  • Purpose

    Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash

    • Protect chafed skin due to diaper rash and helps seal out wetness

  • Warnings:

    For external use only.

    When using this product • do not get into eyes.

    Stop use and ask a doctor if • condition worsens,

    • symptoms last for 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.

  • Directions:

    • Change wet or soiled diapers promptly

    • Cleanse the diaper area

    • Allow to dry

    • Apply cream 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 20° to 25° C (68° to 77° F).

    • Protect from freezing

    • May stain clothing

  • Inactive Ingredients:

    White soft paraffin, Light liquid paraffin, Sorbitan monostearate, Glycerin, Purified water

  • QUESTIONS OR COMMENTS:

    1-866-826-1306 between 11am to 4 pm EST, Monday-Friday (or) mail to delsampharma@yahoo.com

  • SPL UNCLASSIFIED SECTION

    *Compare to the active ingredient in Desitin®Daily Defence

    Protects against diaper rash from the first use

    Free from Parabens, Phthalates, Dyes and Fragrance Hypoallergenic. Pediatrician & Dermatologist tested

    | Works at the first hint of rash | Easy to apply, easy to remove | Gentle enough to use everyday

    Distributed by:
    DELSAM PHARMA LLC
    MAMARONECK NY 10543

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    DIAPERENE CHILDREN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72570-123-16454 g in 1 CONTAINER; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2021
    Labeler - Delsam Pharma Llc (081369679)
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