Label: AUNT KS- oatmeal, colloidal powder
AUNT KS- oatmeal colloidal powder
AUNT KS- oatmeal, collodial powder

  • 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 December 29, 2016

If you are a consumer or patient please visit this version.

  • OTC- Active Ingredients Section

    Organic Colloidal Oatmeal 1.25%..... Skin Protectant

  • Sto use and see a doctor if:

    Conditions worsen

    Symptoms last more than 7 days

    Symptoms clear up and reoccur within a few days.

  • OTC- Warnings Section

    For external use only

    when using this product: Keep away from face to avoid inhalation

    Avoid contact with eyes

    Do not use on wet hair, or allow to dry on wet hair

  • Other information

    Store in a dry place

    protect from moisture

  • OTC- Purpose Section

    Uses: Helps treat and prevent diaper rash

    Temporarily protects and helps relieve minor skin irritation and itching due to diaper rash.

  • Inactive Ingredients

    Powdered White Soft Wheat

  • Keep Out of Reach

    Keep out of reach of Children

  • Dosage section

    Apply as Needed

    Use Generous amounts for best results

  • Indications and usage

    Uses: Helps treat and prevent diaper rash

  • Package Label

    Comfy Bottoms Baby PowerComfy Bottoms Sports PowderComfy Bottoms Foot Powder

  • INGREDIENTS AND APPEARANCE
    AUNT KS 
    oatmeal, colloidal powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23264-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHEAT (UNII: 4J2I0SN84Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23264-200-03113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/14/2014
    AUNT KS 
    oatmeal colloidal powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23264-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHEAT (UNII: 4J2I0SN84Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23264-300-03113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/14/2014
    AUNT KS 
    oatmeal, collodial powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23264-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHEAT (UNII: 4J2I0SN84Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23264-100-03113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/10/2014
    Labeler - Comfy Bottoms, LLC (047137184)
    Registrant - Comfy Bottoms, LLC (047137184)
    Establishment
    NameAddressID/FEIBusiness Operations
    CTL Foods133541248manufacture(23264-200, 23264-100, 23264-300)