Calamine, Pramoxind Hcl Lotion
FDA Label NDC 37808-616

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, Pramoxind Hcl (NDC 37808-616). 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 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 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 (15°–25°C)

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

Questions?

1-888-593-0593

Disclaimer

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

Adverse Reactions

MADE WITH PRIDE & CARE FOR H-E-B ®

SAN ANTONIO, TX 78204

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Compare to Caladryl ®Calamine Itch Reliever*

H-E-B ®

Medicated Calamine Lotion

External Analgesic/Skin Protectant

  • Relieves itching due to insect bites, poison oak or ivy, or other minor skin irritation

    • 6 FL OZ (177 mL)

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.