Nanz Relieve Calamine Lotion

Calamine by

Drug Labeling and Warnings

Calamine 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]

CALAMINE- nanz relieve calamine lotion lotion 
1201258 Ontario Inc. O/A Nanz Pharma

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Nanz Relieve Calamine Lotion

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)

NDC: 83254-075

Labels for all sizes Nanz  Relieve Calamine Lotion Label

CALAMINE 
nanz relieve calamine lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83254-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED7.6 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
BENTONITE (UNII: A3N5ZCN45C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83254-076-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
2NDC: 83254-076-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
3NDC: 83254-076-25225 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
4NDC: 83254-076-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
5NDC: 83254-076-15150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
6NDC: 83254-076-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
7NDC: 83254-076-50250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
8NDC: 83254-076-0050 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
9NDC: 83254-076-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/05/202306/07/2024
Labeler - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
Establishment
NameAddressID/FEIBusiness Operations
1201258 Ontario Inc. O/A Nanz Pharma256906595manufacture(83254-076) , pack(83254-076) , label(83254-076)

Revised: 6/2024
 

Trademark Results [Calamine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CALAMINE
CALAMINE
86788723 4972728 Live/Registered
Stepanek, Julie
2015-10-15

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