Calamine Lotion
FDA Label NDC 11344-136

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Calamine (NDC 11344-136). 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%

Pramoxine HCl 1%

Purpose

Skin protectant

External analgesic

Uses

  • 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 If

  • 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 wash affected area 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: 

Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Principal Display Panel

swan ®

Medicated Calamine Lotion

External Analgesic/Skin Protectant

  • Drying action plus itch relief
  • For relief from pain and itching due to:
  • poison Ivy
  • Poison Sumac
  • Insect Bites
  • Poison Oak
  • Minor Skin Irritations

    • Compare to Caladryl ®Lotion*

    6 FL OZ (177 mL)

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.