Label: THERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT- colloidal oatmeal lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62917-350-01, 62917-350-06 - Packager: The Theraplex Company, LLC
- 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 February 22, 2018
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- Drug Facts
- Active Ingredients
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INGREDIENTS AND APPEARANCE
THERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT
colloidal oatmeal lotionProduct 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)
