CALAMINE- calamine and zinc oxide lotion

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Beli Sekarang

Unduh Karakteristik produk (SPC)
28-12-2023

Bahan aktif:

Calamine 8% and Zinc Oxide 8%

Tersedia dari:

Pharma Nobis, LLC

Rute administrasi :

TOPICAL

Jenis Resep:

OTC DRUG

Indikasi Terapi:

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac. Skin protectant condition worsens, does not improve or if symptoms last more than 7 days, or clear up and occur again within a few days.

Status otorisasi:

OTC monograph final

Karakteristik produk

                                CALAMINE- CALAMINE AND ZINC OXIDE LOTION
PHARMA NOBIS, LLC
----------
FRESKARO CALAMINE LOTION
Drug Facts
ACTIVE INGREDIENTS
Calamine 8% and Zinc Oxide 8%
USES
Dries the oozing and weeping of poison ivy, poison oak, and poison
sumac.
PURPOSE
Skin protectant
WARNINGS
For external use only. Use only as directed.
Avoid contact with eyes and mucous membranes.
Ask a doctor before using on chilren under 2 years of age.
STOP USE AND ASK A DOCTOR IF
condition worsens, does not improve or if symptoms last more than 7
days, or clear up
and occur again within a few days.
KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or
contact a Poison Control
Center (1-800-222-1222) right away.
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, not more than 3 to 4 times daily as
needed for comfort.
Children under 2 years of age: Consult a doctor before use
OTHER INFORMATION
Store at room temperature 15-30C (59-86F)
INACTIVE INGREDIENTS
Avicel, Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water,
and Xanthan Gum
QUESTIONS
Questions or Comments? 1-833-551-0932
LABEL
CALAMINE
calamine and zinc oxide lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82645-418
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED -
UNII:1K09F3G675)
FERRIC OXIDE RED
80 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
80 mg in 1 mL
INACTIVE INGREDIENTS
Pharma Nobis, LLC
INGREDIENT NAME
STRENGTH
BENTONITE (UNII: A3N5ZCN45C)
CARRAGEENAN (UNII: 5C69YCD2YJ)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
M
                                
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