Theraplex
FDA Label NDC 62917-350
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Theraplex Company, Llc for the product Theraplex (NDC 62917-350). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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
Other
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)
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