THERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT- colloidal oatmeal lotion

Theraplex by

Drug Labeling and Warnings

Theraplex by is a Otc medication manufactured, distributed, or labeled by The Theraplex Company, LLC, Memphis Contract Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

THERAPLEX   ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62917-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62917-350-01	128 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2013	07/01/2020
2	NDC: 62917-350-06	170.1 g in 1 JAR; Type 0: Not a Combination Product	01/23/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2013

Labeler - The Theraplex Company, LLC (363529392)

Establishment
Name	Address	ID/FEI	Business Operations
Memphis Contract Packaging, Inc.		185390010	manufacture(62917-350)