Calamine Lotion
FDA Label NDC 55910-063

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Old East Main Co. for the product Calamine (NDC 55910-063). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredientsCalamine 8%Zinc oxide 8%

Otc - Purpose

PurposeSkin protectant

Indications & Usage

Use dries the oozing and weeping of poison:•ivy • oak • sumac

Warnings

WarningsFor external use only

Otc - When Using

When using this product do not get into eyes

Otc - Stop Use

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 the reach of children.  if swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions • shake well before using • apply as needed

Storage And Handling

Other information store at 59⁰ - 86⁰ F

Inactive Ingredient

Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water

Adverse Reactions

Visit us at: Rexall.comor call 1-866-4REXALLDISTRIBUTED BY DOLGENCORP, LLC100 MISSION RIDGEGOODLETTSVILLE, TN 37072 USA

Package Label.Principal Display Panel

Since 1903REXALLCalamine LotionCalamine topical Suspension USP• Poison ivy, oak and sumac drying lotion• Skin protectant6 FL OZ (177 mL)

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