CALAMINE- ferric oxide red lotion

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Calamine 8% Zinc oxide 8%

متاح من:

Dolgencorp, LLC

INN (الاسم الدولي):

FERRIC OXIDE RED

تركيب:

FERRIC OXIDE RED .8 kg in 100 L

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

OTC DRUG

الخصائص العلاجية:

skin protectant dries the oozing and weeping of poison:•ivy • oak • sumac - condition worsens - symptoms last more than 7 days or clear up and occur again wthin a few days

الوضع إذن:

OTC monograph final

خصائص المنتج

CALAMINE - FERRIC OXIDE RED LOTION
DOLGENCORP, LLC
_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._
----------
REXALL 063.001 063AA
ACTIVE INGREDIENTS
Calamine 8%
Zinc oxide 8%
PURPOSE
skin protectant
USE
dries the oozing and weeping of poison:•ivy • oak • sumac
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not get into eyes
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last more than 7 days or clear up and occur again wthin a few
days
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away
DIRECTIONS
• shake well before using • apply as needed
OTHER INFORMATION
store at 59⁰ - 86⁰ F
INACTIVE INGREDIENTS
bentonite magma, calcium hydroxide, glycerin, purified water
Visit us at: Rexall.com
or call 1-866-4REXALL
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA
PRINCIPAL DISPLAY PANEL
Since 1903
REXALL
Calamine Lotion
Calamine Topical Suspension USP
• Poison ivy, oak and sumac drying lotion
• Skin protectant
6 FL OZ (177 mL)
CALAMINE
ferric oxide red lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55910-063
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 OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
80 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:55910-
063-30
177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
04/13/2009
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATIO