CALAMINE- ferric oxide red lotion

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Disponible desde:

Topco Associates LLC

Designación común internacional (DCI):

FERRIC OXIDE RED

Composición:

FERRIC OXIDE RED 8 g in 1 mL

Vía de administración:

TOPICAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

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

Estado de Autorización:

OTC monograph final

Ficha técnica

CALAMINE- FERRIC OXIDE RED LOTION
TOPCO ASSOCIATES 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._
----------
TOP CARE 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 OR COMMENTS?
1888-423-0139
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
TOPCO VIJA0622 QUESTIONS? 1-888-423-0139
1-888-423-0139
[e-mail] www.topcarebrand.com
Visit here for more information:
http://topbrnds.com/4901jk
QUALITY GUARANTEED
PRINCIPAL DISPLAY PANEL
NDC 36800-063-30
TopCare health
Calamine Lotion USP
CALAMINE TOPICAL SUSPENSION USP
SKIN PROTECTANT
Drying Lotion for:
Poison Ivy, Oak & Sumac
6 FL OZ (177 mL)
CALAMINE
ferric oxide red lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:36800-063
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)
Topco Associates LLC
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING E