Calamine, Zinc Oxide Lotion
FDA Label NDC 37808-621

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Calamine, Zinc Oxide (NDC 37808-621). 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 ingredients, 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 Ingredients

Calamine 8%
Zinc oxide 8%

Purpose

Skin protectant

Use

dries the oozing and weeping of poison:

  • ivy 
  • 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 59° - 86°F (15°–30°C)

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Questions?

1-888-593-0593

Adverse Reactions

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H-E-B ®

Calamine Lotion

Calamine Topical Suspension USP

Skin Protectant

  • Dries the oozing and weeping of poison: ivy, oak and sumac

    • 6 FL OZ (177 mL)

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