Drug Facts

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 productdo 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

Rev. 01/2020
Made in Canada

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Caladryl ®
Clear ®
Topical Analgesic ∙ Skin Protectant
Lotion

Drying Action PLUSItch Relief

6 FL OZ (177 mL)

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 Drug	M014	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)