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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83254-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	8 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83254-008-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
2	NDC:83254-008-02	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
3	NDC:83254-008-22	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
4	NDC:83254-008-20	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
5	NDC:83254-008-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
6	NDC:83254-008-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
7	NDC:83254-008-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
8	NDC:83254-008-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
9	NDC:83254-008-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023
10	NDC:83254-008-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	05/05/2023

Labeler - 1201258 Ontario Inc O/A Nanz Pharma (256906595)

Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)

Name	Address	ID/FEI	Business Operations
Establishment
1201258 Ontario Inc. O/A Nanz Pharma		256906595	manufacture(83254-008) , label(83254-008) , pack(83254-008)