CALADRYL CLEAR- pramoxine hydrochloride and zinc acetate 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.

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Caladryl Clear

Drug Facts

Active ingredientsPurpose

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

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®
Clear®
Topical Analgesic ∙ Skin Protectant
Lotion

Drying Action PLUS Itch Relief

6 FL OZ (177 mL)

label.jpg
CALADRYL CLEAR 
pramoxine hydrochloride and zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5466
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5466-06177 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 - Bausch Health US, LLC (831922468)
Establishment
NameAddressID/FEIBusiness Operations
Trillium Health Care Products Inc.255426306MANUFACTURE(0187-5466)

Revised: 1/2020
Document Id: 758f2471-4647-4aea-8034-d5cf18ff5dcb
Set id: fca6f08b-7fa0-4ae6-bce3-61f3bcae4332
Version: 4
Effective Time: 20200101
 
Bausch Health US, LLC