CALAMINE- nanz relieve calamine lotion lotion

Calamine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Calamine 7.6% and Zinc Oxide 7.6%

Purpose

Skin protectant

Uses:

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

Caution & Warnings:

For external use only.Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if symptoms worsen or last for more than 7 days.When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Do not use on broken skin.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

Children under 6 months of age: Consult a doctor before use.

Inactive ingredients

Glycerin, Bentonite, Calcium Hydroxide, Water

Other information:

Store at room temperature 13-30C (50-86F)

PRINCIPAL DISPLAY PANEL

NDC: 83254-075

Labels for all sizes

INGREDIENTS AND APPEARANCE

CALAMINE 
nanz relieve calamine lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83254-075
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	7.6 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.6 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83254-075-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
2	NDC: 83254-075-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
3	NDC: 83254-075-25	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
4	NDC: 83254-075-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
5	NDC: 83254-075-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
6	NDC: 83254-075-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
7	NDC: 83254-075-50	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
8	NDC: 83254-075-00	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023
9	NDC: 83254-075-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2023	07/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	02/09/2023	07/03/2023

Labeler - 1201258 Ontario Inc Nanz Pharma (256906595)

Registrant - 1201258 Ontario Inc Nanz Pharma (256906595)

Establishment
Name	Address	ID/FEI	Business Operations
1201258 Ontario Inc Nanz Pharma		256906595	manufacture(83254-075) , pack(83254-075) , label(83254-075)