Calamine Lotion
FDA Label NDC 11344-063

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Calamine (NDC 11344-063). 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 ingredents, 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 Ingredents

Calamine 8%

Zinc oxide 8%

Purpose

Skin protectant

Use

dries the oozing and weeping of poison:•i vy • oak • sumac

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

Keep Out Of Reach Of Children

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

Directions

  • shake well before using
  • apply as needed

Other Information

store at 59⁰ - 86⁰F

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse Reaction

Vi-Jon, LLC

One Swan Drive

Smyrna, TN 37167

Principal Panel Display

SWAN

Calamine Lotion

  • Calamine topical Suspension USP
  • Skin Protectant
  • Poison Ivy, Oak, Sumac Drying Lotion

    • 6 FL OZ (177 mL)

    Image Description (Mm01)

    Image Description (Mm01)

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