CALADRYL- ferric oxide red, zinc oxide and pramoxine hydrochloride lotion 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

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?

call 1-800-223-0182

Dist: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558 USA

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:58232-0730
Route of AdministrationTOPICALDEA Schedule    
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)  
Hypromelloses (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:58232-0730-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/17/201205/31/2015
Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 1/2015
Document Id: b554d520-4c27-4052-b219-2aa845a8cfae
Set id: c67a93fb-9291-48cb-8777-ab4de4367ff6
Version: 4
Effective Time: 20150120
 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.