CALAMINE ferric oxide red lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)

Available from:

Kmart Corporation

INN (International Name):

FERRIC OXIDE RED

Composition:

FERRIC OXIDE RED .8 kg in 100 L

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

CALAMINE - FERRIC OXIDE RED LOTION
KMART CORPORATION
_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._
----------
DRUG FACTS
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 within a few days
KEEP OUT OF THE 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 59 - 86 F
INACTIVE INGREDIENTS bentonite magma, calcium hydroxide, glycerin,
purified water
Distributed by:
Kmart Corporation
Hoffman Estates, IL 60179
Shop kmart.com
Satisfaction guarantee
If you are unsatisfied for any reason,
return the unused portion to the store
for a full refund or call
1-800-842-7889
Smart
Sense
SKIN PROTECTANT
CALAMINE
LOTION
CALAMINE TOPICAL SUSPENSION USP
Drying Lotion Treats:
Poison Ivy, Oak
and Sumac
6 FL OZ (177 mL)
CALAMINE
ferric oxide red lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 738 -0 6 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75) (FERRIC OXIDE RED - UNII:1K0 9
F3G6 75)
FERRIC OXIDE RED
.8 kg in 10 0 L
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
.8 kg in 10 0 L
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CALCIUM HYDRO XIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6 A3C0 OX)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:49 738 -0 6 3-30
.177 L in 1 BOTTLE, PLASTIC
Kmart Corporation
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOG