CALADRYL- ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion

Caladryl by

Drug Labeling and Warnings

Caladryl by is a Otc medication manufactured, distributed, or labeled by Bausch Health US, LLC, Trillium Health Care Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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

SPL UNCLASSIFIED SECTION

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

©2020 Bausch Health Companies Inc. or its affiliates

Rev. 01/2020

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)

INGREDIENTS AND APPEARANCE

CALADRYL 
ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5465
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675)	Ferric Oxide Red	1.36 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	78.65 mg  in 1 mL
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5465-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/16/2013

Labeler - Bausch Health US, LLC (831922488)

Establishment
Name	Address	ID/FEI	Business Operations
Trillium Health Care Products Inc.		255426306	MANUFACTURE(0187-5465)