Calamine Lotion
FDA Label NDC 79481-0336

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Calamine (NDC 79481-0336). 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 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, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Other

*This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Lotion

DIST. BY MEIJER

DISRIBUTION, INC

GRAND RAPIDS, MN 49544

www.meijer.com

Principal Display Panel

NDC 41250-888-30

Compare to Caladryl Lotion

Meijer

MEDICATED

calamine lotion

External Analgesic/Skin Protectant

Drying Action Plus Itch Relief

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

6 FL OZ (177 mL)

Image Description (Mm3)

Image Description (Mm3)

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