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), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Walgreen Co.

INN (International Name):

FERRIC OXIDE RED

Composition:

FERRIC OXIDE RED 8 g in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 within a few days

Authorization status:

OTC monograph final

Summary of Product characteristics

CALAMINE - FERRIC OXIDE RED LOTION
WALGREEN CO.
_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._
----------
WALGREENS 063.001/063AA
ACTIVE INGREDENTS
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 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
QUESTIONS
1-888-593-0593
DISCLAIMER
Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey Study, November 2016
ADVERSE REACTIONS
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL
100% SATISFACTION GUARANTEED
walgreens.com 2016 Walgreen Co
MADE IN U.S.A. WITH U.S. AND FOREIGN COMPENENTS
PRINCIPAL DISPLAY PANEL
Walgreens
Calamine
Lotion
CALAMINE TOPICAL
SUSPENSION USP/
SKIN PROTECTANT
Poison ivy, oak & sumac drying lotion
6 FL OZ (177 mL)
CALAMINE
ferric oxide red lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0363-0224
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
8 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
8 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENTONITE (UNII: A3N5ZCN45C)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
Walgreen Co.
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0363-
0224-30
1