Caladryl Pink

Caladryl Pink

Drug Labeling and Warnings

Drug Details

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CALADRYL- ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion 
Valeant Pharmaceuticals North America 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.

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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)

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
CALADRYL 
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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Methylparaben (UNII: A2I8C7HI9T)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#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 - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Trillium Health Care Products Inc.255426306MANUFACTURE(0187-5465)

Revised: 12/2018
 
Valeant Pharmaceuticals North America LLC


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