Calamine Lotion
FDA Label NDC 41163-536

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Calamine (NDC 41163-536). 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, 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%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Use

  • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • 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

  • condition worsens
  • symptoms last more than 7 days or clean 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 applying was affected are of skin

    • 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 - do not use, ask a doctor

Other Information

store at room temperature (59°-77°F)

Inactive Ingredients

alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol,
Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

Other

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company distributor of Caladryl Lotion

Distributed by Supervalu Inc.

Eden Prairie, MN 55344 USA

Contact us at 1-877-932-7948 or www.sumpervalu-ourownbrands.com

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Compare to Caladryl Lotion active ingredient*

EQUALINE

medicated calamine lotion

external analgesic

skin protectant

drying action plus itch relief

6 FL OZ (177 mL)

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