Calamine Lotion
FDA Label NDC 46122-809

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Calamine (NDC 46122-809). 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, uses, 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

Uses

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 
  • Preserve in tight containers

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Questions?

1-888-593-0593

Adverse Reaction

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

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NDC 46122-809-29

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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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