CALAMINE- ferric oxide red lotion

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Major Pharmaceuticals

INN (Rahvusvaheline Nimetus):

FERRIC OXIDE RED

Koostis:

FERRIC OXIDE RED 8 g in 1 mL

Manustamisviis:

TOPICAL

Retsepti tüüp:

OTC DRUG

Näidustused:

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

Volitamisolek:

OTC monograph final

Toote omadused

CALAMINE- FERRIC OXIDE RED LOTION
MAJOR PHARMACEUTICALS
_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._
----------
MAJOR 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?
[phone]
ADVERSE REACTIONS
Distributed By:
MAJOR PHARMACEUTICALS
17177 N LAUREL PARK DRIVE, SUITE 233
Livonia, MI 48152
Re-Order No 014282 M-97
Rev. 10/16
PRINCIPAL DISPLAY PANEL
NDC 0904-2533-21
MAJOR
Calamine
Lotion
Calamine Topical Suspension USP
Skin Protectant
Poison Ivy, Oak, Sumac
Drying Lotion
Shake well before using
6 FL OZ (177 mL)
CALAMINE
ferric oxide red lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0904-2533
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)
Major Pharmaceuticals
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0904-
2533-21
177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Product