FDA Label for Caladryl Clear
View Indications, Usage & Precautions
Caladryl Clear Product Label
The following document was submitted to the FDA by the labeler of this product Bausch Health Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
Dist by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
©2013 Valeant Pharmaceuticals North America LLC
Rev. 01/13
Made in Canada
Otc - Purpose
Active ingredients | Purpose |
---|---|
Pramoxine HCl 1% | Topical analgesic |
Zinc acetate 0.1% | Skin protectant |
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, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate
Questions/Comments
call 1-800-321-4576
Principal Display Panel - 177 Ml Bottle Label
Caladryl®
Clear®
Topical Analgesic ∙ Skin Protectant
Lotion
Drying Action PLUS Itch Relief
6 FL OZ (177 mL)
* Please review the disclaimer below.