CALAMINE- nanz relieve calamine lotion lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Calamine 7.6% and Zinc Oxide 7.6%

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 insect bites, sunburn, poison ivy, sumac, and poison oak.

Authorization status:

OTC monograph final

Summary of Product characteristics

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
CALAMINE
nanz relieve calamine lotion lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:83254-076
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED -
7.6 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED -
UNII:1K09F3G675)
FERRIC OXIDE RED
7.6 g
in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZI