CBDMEDIC ECZEMA- colloidal oatmeal ointment 
AIDANCE SKINCARE & TOPICAL SOLUTIONS, 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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CBDMEDIC Eczema

Active Ingredients and Purpose

Colloidal Oatmeal 1% (Skin Protectant)

Uses

To relieve symptoms associated with eczema, psoriasis, and severe dry, itchy and flaky skin.

Warnings

For external use only. Do not use on wounds or damaged skin. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult a physician.

If pregnant or breast feeding, contact a physician prior to use. Keep out of reach of children. If swallowed, consult a physician.

Directions:

Adults and children 12 years of age and older: Massage into affected skin. Reapply up to 4 times daily. Store at room temperature.
Children under 12 years of age: ask a doctor.

Inactive ingredients

Beeswax (organic), chamomile oil, cotton seed oil, eucalyptus oil, hemp extract (THC-free), jojoba seed oil, peppermint oil, silver oxide, sorbic acid, stearic acid (vegetable derived), zinc oxide.

PRINCIPAL DISPLAY PANEL

CBDMEDIC Eczema

CBDMEDIC ECZEMA 
colloidal oatmeal ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
COTTONSEED OIL (UNII: H3E878020N)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HEMP (UNII: TD1MUT01Q7)  
JOJOBA OIL (UNII: 724GKU717M)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILVER OXIDE (UNII: 897WUN6G6T)  
SORBIC ACID (UNII: X045WJ989B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-730-401 in 1 CARTON03/06/2019
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/06/2019
Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-730) , label(24909-730)

Revised: 3/2019
Document Id: 2dbd4295-d1f0-4c71-8647-bf13dbb75f52
Set id: 5436754f-c025-4b1c-811f-1232dc80dad4
Version: 1
Effective Time: 20190306
 
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC