FDA Label for Diaper Rash

View Indications, Usage & Precautions

Diaper Rash Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Co. 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 Ingredient



Zinc oxide  40%


Purpose



Skin protectant


Uses



• helps treat and prevent diaper rash
• protects chafed skin due to the 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 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 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, tocoperyl acetate, fragrance


Questions



1-855-200-BABY  www.ComfortsForBaby.com


Adverse Reaction



DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202

020.002/020AC


Principal Display Panel



NDC 30142-020-26

COMFORTS

Maximum Strength Diaper Rash Ointment

40% Zinc Oxide Skin Protectant

  • Helps Heal, Soothe & Prevent Diaper Rash
  • Seals out wetness
  • Hypoallergenic
  • Gentle on baby's skin
  • Paraben free

    NET WT 4 OZ (113 g)

    020.001/020AB


* Please review the disclaimer below.