FDA Label for Creamy Diaper Rash

View Indications, Usage & Precautions

Creamy 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 13%


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
  • 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 25⁰ C (68⁰ - 77⁰ F)


Inactive Ingredients



water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol


Adverse Reaction



DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

226.002/226AD


Principal Display Panel



COMFORTS FOR BABY

Skin Protectant

Creamy Diaper Rash Ointment

Aloe, Vitamin E, + Zinc Oxide

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