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NDC 00187-5466-06 Caladryl Clear 10; 1 mg/mL; mg/mL Details

Caladryl Clear 10; 1 mg/mL; mg/mL

Caladryl Clear is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch Health US, LLC. The primary component is PRAMOXINE HYDROCHLORIDE; ZINC ACETATE.

Product Information

NDC	00187-5466
Product ID	0187-5466_758f2471-4647-4aea-8034-d5cf18ff5dcb
Associated GPIs	90859902954120
GCN Sequence Number	035594
GCN Sequence Number Description	pramoxine HCl/zinc acetate LOTION 1 %-0.1 % TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	96616
HICL Sequence Number	013244
HICL Sequence Number Description	PRAMOXINE HCL/ZINC ACETATE
Brand/Generic	Brand
Proprietary Name	Caladryl Clear
Proprietary Name Suffix	n/a
Non-Proprietary Name	PRAMOXINE HYDROCHLORIDE and ZINC ACETATE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10; 1
Active Ingredient Units	mg/mL; mg/mL
Substance Name	PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Labeler Name	Bausch Health US, LLC
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00187-5466-06 (00187546606)

Pricing Information	N/A
NDC Package Code	0187-5466-06
Billing NDC	00187546606
Package	177 mL in 1 BOTTLE, PLASTIC (0187-5466-06)
Marketing Start Date	2013-08-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fca6f08b-7fa0-4ae6-bce3-61f3bcae4332 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Pramoxine HCl 1%	Topical analgesic
Zinc acetate 0.1%	Skin protectant

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, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

Questions/Comments

call 1-800-321-4576

SPL UNCLASSIFIED SECTION

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

Rev. 01/2020

Made in Canada

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Caladryl®

Clear®

Topical Analgesic ∙ Skin Protectant

Lotion

Drying Action PLUS Itch Relief

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CALADRYL CLEAR

pramoxine hydrochloride and zinc acetate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0187-5466
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Camphor (Synthetic) (UNII: 5TJD82A1ET)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Polysorbate 40 (UNII: STI11B5A2X)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0187-5466-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2013

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

Labeler - Bausch Health US, LLC (831922468)

Name	Address	ID/FEI	Business Operations
Establishment
Trillium Health Care Products Inc.		255426306	MANUFACTURE(0187-5466)

Revised: 1/2020

Document Id: 758f2471-4647-4aea-8034-d5cf18ff5dcb

Set id: fca6f08b-7fa0-4ae6-bce3-61f3bcae4332

Version: 4

Effective Time: 20200101

Search by Drug Name or NDC

NDC 00187-5466-06 Caladryl Clear 10; 1 mg/mL; mg/mL Details

Caladryl Clear 10; 1 mg/mL; mg/mL

Product Information

Package

Package Images

NDC 00187-5466-06 (00187546606)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL fca6f08b-7fa0-4ae6-bce3-61f3bcae4332 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions/Comments

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

INGREDIENTS AND APPEARANCE

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