Viaderma Calm Anti-itch Ointment
FDA Label NDC 71262-014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Viaderma Distribution, Inc. for the product Viaderma Calm Anti-itch (NDC 71262-014). 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, purposes, uses, warnings, do not use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

Hydrocortisone 1%

Purposes

Anti-Itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema • detergents
• insect bites • cosmetics
• poison ivy • jewelry
• poison oak • seborrheic dermatitis
• poison sumac • psoriasis
• soaps

Warnings

For external use only.

Avoid contact with the eyes

Do Not Use

  • it for the treatment of diaper rash
  • Consult a doctor

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, consult a doctor.

Other Ingredients

Acetic acid, ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, gluconolactone, glycerin, histidine, hydroxyethyl-cellulose, magnesium stearate, sodium hydroxide, sorbic acid, water.

Questions?

Report any serious adverse events
to: Viaderma Distribution Inc. or call:
1-800-585-8685.
Email: www.viadermainc.com

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