CALADRYL CLEAR- pramoxine hydrochloride and zinc acetate lotion

Caladryl Clear by

Drug Labeling and Warnings

Caladryl Clear by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America 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
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

Dist by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

©2013 Valeant Pharmaceuticals North America LLC

Rev. 01/13
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5466-06	177 mL in 1 BOTTLE, PLASTIC

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

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

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