FDA Label for Coolbottoms Diaper Rash

View Indications, Usage & Precautions

Coolbottoms Diaper Rash Product Label

The following document was submitted to the FDA by the labeler of this product Ph R&d 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 Ingredient



Dimethicone 1%


Purpose



Skin protectant


Uses



  • helps treat diaper rash
  • temporarily protects and helps relieve chapped or cracked skin
  • protects chafed skin as associated with diaper rash and helps seal out wetness

Warnings



For external use only


When Using This Product



  • Keep out of eyes.
    Rinse eyes thoroughly with water to remove.

Directions



  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, especially at bedtime when exposure to wet diapers may be prolonged.

Inactive Ingredients



Water, Mineral Oil, White Petrolatum, Sorbitol, Ceresine, Sorbitan Sesquioleate, Lanolin Alcohol, Phenoxyethanol, Magnesium Hydroxide, Ethylhexylglycerin, BHT


Questions?



M-F CST Call: 1-877-725-RASH


Principal Display Panel - 57G Jar Carton



developed by a
pediatrician

PATENTED
Cool
bottoms®
DIAPER RASH CREAM
skin protectant
cools and soothes

NET WT 2 OZ (57g)


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