Active Ingredient
Calamine 8%
Pramoxine HCI 1%
Calahist Lotion
FDA Label NDC 0363-9411
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Calahist (NDC 0363-9411). 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 ingredient, 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
Purpose
Skin protectant
External analgesic
Uses
■ Dries the oozing and weeping of poison:
■ ivy ■ oak ■ sumac
■ For the temporary relief of pain and itching associated with
■ minor skin irritations ■ rashes due to poison ivy, poison oak, or poison sumac
■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites
Warnings
■ For external use only ■ Use only as directed.
When Using This Product
do not get into eyes
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.
Directions
■ shake well before using ■ cleanse the skin with soap and water ■ let dry before each use ■ apply lotion to the affected area using cotton or soft cloth
| adults and children 2 years and older | Not more than 3 to 4 times daily as needed for comfort |
| children under 2 years | Consult a doctor before use |
Other Information
Store at room temperature 15°- 30°C (59° - 86°F)
Inactive Ingredients
SD alcohol 38B 2.5%, camphor, diazolidinyl urea, fragrances, glycerin, hydroxypropyl methylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben and purified water
Questions Or Comments?
1-888-235-2466
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DISTRIBUTED BY:
WALGREEN CO., DEERFIELD, IL 60015
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Walgreens Pharmacist Recommended. Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by Bausch Health US, distributor of Caladryl® Lotion.
L0000729
R0723
Package Label.Principal Display Panel
NDC 0363-9411-97
Walgreens
Compare to the active ingredients
in Caladryl® Lotion
††
Calahist
MEDICATED CALAMINE LOTION /
EXTERNAL ANALGESIC /
SKIN PROTECTANT
Itch Relief
• Drying action plus itch relief
6 FL OZ (177 mL)
Image001 (Image001)
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