Calamine Lotion
FDA Label NDC 83324-053

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Calamine (NDC 83324-053). 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, 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

Uses

  • for the temporary relief of pain and itching associated with minot 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

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl Lotion Calamine Plus Itch Reliever.

Adverse Reaction

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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100% QC

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NDC 83324-053-06

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QUALITY CHOICE

*Compare to CALADRYL

Medicated

Calamine

Lotion

External Analgesic/Skin Protectant

For relief from pain and itching due to:

Poison Ivy, Poison Sumac, Insect Bites, Poison Oak & Minor Skin Irritations

6 FL OZ (177 mL)

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Image Description (Mm01)

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