CALADRYL- ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion 
Bausch Health US, LLC

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


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


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.


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


call 1-800-321-4576

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

©2020 Bausch Health Companies Inc. or its affiliates

Rev. 01/2020

Made in Canada



Topical Analgesic ∙ Skin Protectant

Calamine Plus Itch Reliever

6 FL OZ (177 mL)

ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5465
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675) Ferric Oxide Red1.36 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide78.65 mg  in 1 mL
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Camphor (Synthetic) (UNII: 5TJD82A1ET)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Methylparaben (UNII: A2I8C7HI9T)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5465-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/16/2013
Labeler - Bausch Health US, LLC (831922468)
NameAddressID/FEIBusiness Operations
Trillium Health Care Products Inc.255426306MANUFACTURE(0187-5465)

Revised: 1/2020
Document Id: c2b35f23-4193-4877-a079-1405d88246b6
Set id: 67d4fd42-9fed-4238-9f5a-c9403abbcf20
Version: 5
Effective Time: 20200101
Bausch Health US, LLC