THERAPLEX  ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT- colloidal oatmeal lotion 
The Theraplex Company, 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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Theraplex 

Drug Facts

Active Ingredients

Colloidal Oatmeal 1% 

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to: • eczema • rashes

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed, or as directed by your doctor.

Other information

• store at room temperature  • keep from freezing

Inactive Ingredients

cyclomethicone,microcrystalline wax, petrolatum(special fraction)

Questions?

call 1-888-437-2753

Does not contain antibiotics.

Not tested on animals.

Distributed by:

The Theraplex Company, LLC

Memphis,TN 38119

Steroid Free

Fragrance Free

Paraben Free

Preservative Free

Gluten Free

Noncomedogenic

Hypoallergenic

Packaging

image description

THERAPLEX   ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62917-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62917-350-01128 g in 1 TUBE; Type 0: Not a Combination Product11/01/201307/01/2020
2NDC:62917-350-06170.1 g in 1 JAR; Type 0: Not a Combination Product01/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2013
Labeler - The Theraplex Company, LLC (363529392)
Establishment
NameAddressID/FEIBusiness Operations
Memphis Contract Packaging, Inc.185390010manufacture(62917-350)

Revised: 2/2018
Document Id: 9d6e2374-7834-46e5-a368-2f5918706ebf
Set id: 47b50665-1909-411f-b6e0-d24602811c99
Version: 5
Effective Time: 20180222
 
The Theraplex Company, LLC