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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 finalM01605/05/2023
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: 5/2023
Document Id: fbfb2125-9110-8d05-e053-6394a90a8b61
Set id: f1ecb705-b0cc-b58d-e053-2a95a90a6d0f
Version: 7
Effective Time: 20230518
 
1201258 Ontario Inc. O/A Nanz Pharma