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:

Wakefern Food Corp

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
WAKEFERN FOOD CORP
_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._
----------
SHOP RITE 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
ADVERSE REACTION SECTION
DISTRIBUTED BY
WAKEFERN FOOD CORP.
5000 RIVERSIDE DRIVE
KEASBEY, NJ 08832
PRINCIPAL DISPLAY PANEL
ShopRite
SKIN PROTECTANT
CALAMINE
LOTION
CALAMINE TOPICAL SUSPENSION U.S.P.
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:41190-063
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)
Wakefern Food Corp
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:41190-
063-30
177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product
07/15/1989
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MAR