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Caladryl

Dosage form: lotion
Ingredients: Ferric Oxide Red 1.36mg in 1mL, Zinc Oxide 78.65mg in 1mL, Pramoxine Hydrochloride 10mg in 1mL
Labeler: Valeant Pharmaceuticals North America LLC
NDC Code: 0187-5465

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Caladryl Pink

Drug Facts

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.

When using this product do not get into eyes

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

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

Dist by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

©2013 Valeant Pharmaceuticals North America LLC

Rev. 01/13
Made in Canada

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Caladryl®

Topical Analgesic ∙ Skin Protectant
Lotion

Calamine Plus Itch Reliever

6 FL OZ (177 mL)

CALADRYL 
ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5465
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ferric Oxide Red (Ferric Oxide Red) Ferric Oxide Red1.36 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide78.65 mg  in 1 mL
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic) 
Diazolidinyl Urea 
Hypromelloses 
Methylparaben 
Polysorbate 80 
Propylene Glycol 
Propylparaben 
Water 
Xanthan Gum 
Packaging
#Item CodePackage Description
1NDC:0187-5465-06177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/16/2013
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIOperations
Trillium Health Care Products Inc.255426306MANUFACTURE(0187-5465)

Revised: 08/2013
 
Valeant Pharmaceuticals North America LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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