Nanz Aloe Vera Calamine Lotion

Aloe Vera Calamine by

Drug Labeling and Warnings

Aloe Vera Calamine 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]

ALOE VERA CALAMINE- nanz aloe vera calamine lotion lotion 
1201258 Ontario Inc O/A Nanz Pharma

----------

Nanz Aloe Vera Calamine Lotion

Active Ingredients

Calamine Lotion 8%

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:

Aloe Barbadensis Leaf Juice, Light liquid paraffin, Glycerin, Cetostearyl alcohol, Cetomacrogol 1000, White petroleum jelly, Propylene glycol, Fragrance, Methylparaben, Propylparaben, Purified water.

Storage

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

Label

Nanz  Aloe Vera Calamine Lotion Label

ALOE VERA CALAMINE 
nanz aloe vera calamine lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83254-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) 10 g  in 100 mL
FRAGRANCE 13576 (UNII: 5EM498GW35)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X) 10 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83254-008-15150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
2NDC: 83254-008-0220 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
3NDC: 83254-008-22225 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
4NDC: 83254-008-202000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
5NDC: 83254-008-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
6NDC: 83254-008-25250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
7NDC: 83254-008-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
8NDC: 83254-008-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
9NDC: 83254-008-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
10NDC: 83254-008-0660 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(83254-008) , label(83254-008) , pack(83254-008)

Revised: 6/2024