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Drug Facts
Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
©2020 Bausch Health Companies Inc. or its affiliates
Rev. 01/2020
Made in Canada
Caladryl Lotion
FDA Label NDC 0187-5465
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bausch Health Us, Llc for the product Caladryl (NDC 0187-5465). 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 other, otc - purpose, uses, warnings, otc - when using, otc - ask doctor, otc - 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
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
Calamine 8% | Skin protectant |
Pramoxine HCl 1% | Topical analgesic |
Uses
- temporarily relieves pain and itching associated with:
- rashes due to poison ivy, poison oak or poison sumac
- insect bites
- minor skin irritation
- minor cuts
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
Warnings
For external use only.
Otc - When Using
When using this product do not get into eyes
Otc - Ask Doctor
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- shake well before use
- 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: ask a doctor
Other Information
- store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum
Questions/Comments
call 1-800-321-4576
Principal Display Panel - 177 Ml Bottle Label
Caladryl®
Topical Analgesic ∙ Skin Protectant
Lotion
Calamine Plus Itch Reliever
6 FL OZ (177 mL)
Label.jpg (Label)
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