Nanz Pure by 1201258 Ontario Inc.O/A Nanz Pharma / 1201258 Ontario Inc. O/A Nanz Pharma Pure Calamine Lotion 19%

Nanz Pure by

Drug Labeling and Warnings

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

Drug Details [pdf]

NANZ PURE- calamine lotion liquid 
1201258 Ontario Inc.O/A Nanz Pharma

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Pure Calamine Lotion 19%

Active Ingredients:

Calamine 19% Zinc Oxide 19%

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. I contact occurs, rinse thoroughly with water.

Stop use and as/consult a doctor/physician/healthcare practitioner/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 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. Children under 6 months of age: consult a doctor before use.

Other information:

Store at room temperature 50-86F

Inactive Ingredients:

Glycerin, Bentonite, Calcium hydroxide, water

Distributed by:

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

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

Package Label

For all bottle sizes. A tentative Label

NANZ PURE 
calamine lotion liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83254-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	19 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83254-019-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
2	NDC: 83254-019-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
3	NDC: 83254-019-20	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
4	NDC: 83254-019-02	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
5	NDC: 83254-019-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
6	NDC: 83254-019-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
7	NDC: 83254-019-55	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2023
8	NDC: 83254-019-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
9	NDC: 83254-019-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023
10	NDC: 83254-019-22	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/15/2023	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(83254-019) , pack(83254-019) , label(83254-019)

Revised: 6/2024

Document Id: 1a4f8696-5fed-5759-e063-6394a90a425d

34390-5

Set id: f49b40e1-2e36-7174-e053-2995a90af1a3

Version: 5

Effective Time: 20240607