AUNT KS- oatmeal, colloidal powder 
Comfy Bottoms, LLC

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.

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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

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)

Revised: 12/2016
Document Id: 44d0bc8a-ec26-43e7-e054-00144ff8d46c
Set id: 0748e489-ad72-2db5-e054-00144ff88e88
Version: 4
Effective Time: 20161229
 
Comfy Bottoms, LLC