CALANANZ- calamine lotion 15% lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)

Available from:

1201258 Ontario Inc. O/A Nanz Pharma

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

CALANANZ- CALAMINE LOTION 15% 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._
----------
CALANANZ LOTION, CALALAYER LOTION
ACTIVE INGREDIENTS:
Calamine 15%, Zinc Oxide 5%
PURPOSE
Skin protectant
USES:
For temporary relief of skin irritations and itching caused by
sunburn, poison ivy, sumac,
and poison oak.
CAUTION AND WARNINGS:
FOR EXTERNAL USE ONLY. Use only as directed
When using this product, avoid contact with eyes. If contact occurs,
rinse thoroughly
with water.
Stop use and ask/consult a doctor/physician/healthcare pratitioner/
healthcare provider/
healthcare professional if symptoms worsen or last for more than 7
days.
Do not use on broken skin.
KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or
contact Poison Control
Center immediately.
DIRECTIONS
Adults and children 2 years of age and older. Shake well before using.
Cleanse the skin
with soap and water and let dry before each use. Apply lotion to the
affected area using
cotton or soft cloth, as often as needed for comfort. For children
under 6 months of
age, consult a doctor before use.
OTHER INFORMATION:
Store at room temperature 50-86F
INACTIVE INGREDIENTS:
Bentonite, Carboxymethylcellulose Sodium, Fragrance, Glycerin,
Isopropyl Alcohol, PEG-
40 hydrogenated castor oil, Phenol, Sodium citrate, Water
DISTRIBUTED BY:
1201258 Ontario Inc. Nanz Pharma, 575 Granite Court, Pickering, ON L1W
3K1
Questions or Comments: ###-###-####
LABEL
Label for all sizes. Tentative design
CALANANZ
calamine lotion 15% lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:83254-015
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
5 g in 100 mL
FERRIC OXIDE RED (UNII: 1K09F3G675)