1. Home
  2. Labeler Index
  3. Bausch Health Us, Llc
  4. 0187-5465
  5. Label Information: Caladryl

FDA Label for Caladryl

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - ASK DOCTOR
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS/COMMENTS
    12. PRINCIPAL DISPLAY PANEL - 177 ML BOTTLE LABEL

Caladryl 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.

Other



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


Otc - Purpose



Active ingredientsPurpose

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

label.jpg - label


* Please review the disclaimer below.