1. Home
  2. Labeler Index
  3. Topco Associates Llc
  4. 36800-020
  5. Label Information: Diaper Rash

FDA Label for Diaper Rash

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. ADVERSE REACTIONS
    12. DISCLAIMER
    13. PRINCIPAL DISPLAY PANEL

Diaper Rash Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



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


When Using This Product



  • do not get into 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.


Directions



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

Other Information



store between 20⁰ and 25⁰C (68⁰ and 77⁰F)


Inactive Ingredients



petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance


Adverse Reactions



DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 1-888-423-0139

tippytoesbytopcare.com

020.002/020AC


Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company,

distributor of Desitin Maximum Strength Original Paste.


Principal Display Panel



NDC 36800-020-26

tippy toes

by TopCare

40% zinc oxide

diaper rash ointment

skin protectant

helps heal, soothe & prevent diaper rash

hypoallergenic

maximum strength

COMPARE TO DESITIN MAXIMUM STRENGTH ORIGINAL PASTE

NET WT 4 OZ (113 g)


* Please review the disclaimer below.