Calananz Lotion, Calalayer Lotion

Calananz by

Drug Labeling and Warnings

Calananz by is a Otc medication manufactured, distributed, or labeled by 1201258 Ontario Inc. O/A Nanz Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALANANZ- calamine lotion 15% lotion 
1201258 Ontario Inc. O/A Nanz Pharma

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Calananz Lotion, Calalayer Lotion

Active Ingredients:

Calamine 15%, Zinc Oxide 5%

Purpose

Skin protectant

Uses:

For temporary relief of skin irritations and itching caused by sunburn, poison ivy, sumac, and poison oak.

Caution and Warnings:

FOR EXTERNAL USE ONLY. Use only as directed

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask/consult a doctor/physician/healthcare pratitioner/ healthcare provider/ healthcare professional if symptoms worsen or last for more than 7 days.

Do not use on broken skin.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately.

Directions

Adults and children 2 years of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. For children under 6 months of age, consult a doctor before use.

Other information:

Store at room temperature 50-86F

Inactive Ingredients:

Bentonite, Carboxymethylcellulose Sodium, Fragrance, Glycerin, Isopropyl Alcohol, PEG-40 hydrogenated castor oil, Phenol, Sodium citrate, Water

Distributed by:

1201258 Ontario Inc. Nanz Pharma, 575 Granite Court, Pickering, ON L1W 3K1

Questions or Comments: ###-###-####

Label

Label for all sizes. Tentative design

CALANANZ 
calamine lotion 15% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83254-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 100 mL
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PHENOL (UNII: 339NCG44TV)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
FRAGRANCE 13576 (UNII: 5EM498GW35)
WATER (UNII: 059QF0KO0R)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83254-015-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023
2	NDC: 83254-015-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023
3	NDC: 83254-015-20	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023
4	NDC: 83254-015-02	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2023
5	NDC: 83254-015-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023
6	NDC: 83254-015-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023
7	NDC: 83254-015-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023
8	NDC: 83254-015-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023
9	NDC: 83254-015-22	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023	07/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/07/2023	06/07/2024

Labeler - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)

Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)

Establishment
Name	Address	ID/FEI	Business Operations
1201258 Ontario Inc. O/A Nanz Pharma		256906595	manufacture(83254-015) , label(83254-015) , pack(83254-015)

Revised: 6/2024

Document Id: 1a4f9165-e666-8452-e063-6294a90a4061

34390-5

Set id: f4c13db8-a0f8-5713-e053-2995a90a0ae5

Version: 4

Effective Time: 20240607