Sarna
FDA Label NDC 54868-1587

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Sarna (NDC 54868-1587). 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 active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Pramoxine hydrochloride 1%

Purpose

external analgesic

Use

for the temporary relief of itching associated with minor skin irritations

Warnings

For external use only

When Using This Product

  • avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

    • Caution -- Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • To open, squeeze cap tightly and turn pump counter-clockwise.

    • 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: consult a doctor. 

Other Information

Side effects may be reported to 1-888-438-7426

Inactive Ingredients

benzyl alcohol, carbomer 940, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water, sodium hydroxide, stearic acid

Find more about Sarna!

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

www.sarna-skincare.com

Made in Canada

A099718

Other

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

Principal Display Panel

NDC 54868-1587-0

Sarna®

SENSITIVE

Pramoxine Hydrochloride 1%

ANTI-ITCH LOTION

Steroid-Free and Fragrance-Free

DERMATOLOGIST Recommended

  • Relieves itching associated with:

    • DRY, SENSITIVE SKIN

    ECZEMA

    • Moisturizing

      • Net Wt. 7.5 Fl Oz. (222 mL)

      A099717

      Sarna Sensitive 7.5 Fl. Oz. (222 mL) Front Label (1587)

      Sarna Sensitive 7.5 Fl. Oz. (222 mL) Front Label (1587)

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