OTC Medication Information: Caladryl

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.

Drug Facts

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

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)

//otclabels.com/lib/images-otc/caladryl-3/label-300x158.jpg
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ferric Oxide Red (Ferric Oxide Red) Ferric Oxide Red 1.36 mg in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 78.65 mg in 1 mL
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Camphor (Synthetic)
Diazolidinyl Urea
HYPROMELLOSE, UNSPECIFIED
Methylparaben
Polysorbate 80
Propylene Glycol
Propylparaben
Water
Xanthan Gum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-5465-06 177 mL in 1 BOTTLE, PLASTIC None
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 Operations
Trillium Health Care Products Inc. 255426306 MANUFACTURE (0187-5465)

Revised: 01/2020 Bausch Health US, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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