Theraplex
FDA Label NDC 62917-819

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 62917-819). 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 ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
•eczema •soaps •detergents •cosmetics •seborrheic dermatitis •psoriasis. •Other uses of this product should only be under the advice and supervision of a doctor.

Warnings

For external use only

• Do not use for the treatment of diaper rash, consult a doctor.

• When using this product, avoid contact with eyes.

• Stop use and ask a doctor if condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.

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

• Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: do not use, ask a doctor.

Inactive Ingredients

Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

Other Information

• Store at 20° to 25°C (68° to 77°F)

Questions?

• Toll-free number 888-437-2753 • For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

Packaging

Therplx3 (Label)

Therplx3 (Label)

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