FIRST AID ONLY POVIDONE-IODINE PREP PAD- povidone-iodine patch

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

Διαθέσιμο από:

Acme United Corporation

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

OTC DRUG

Θεραπευτικές ενδείξεις:

Purpose Antiseptic Use Antispetic for preparation of the skin.

Καθεστώς αδειοδότησης:

OTC monograph not final

Αρχείο Π.Χ.Π.

FIRST AID ONLY POVIDONE-IODINE PREP PAD- POVIDONE-IODINE PATCH
ACME UNITED 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._
----------
FIRST AID ONLY POVIDONE-IODINE PREP PAD
ACTIVE INGREDIENTS
ACTIVE INGREDIENTS Povidone Iodine 10%
PURPOS E
PURPOSE Antiseptic
US E
USE Antispetic for preparation of the skin.
WARNINGS
WARNINGS •For external use only.
•Discontinue use if irritation and redness develop.
•Keep out of reach of children.
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
DIRECTIONS Apply locally as needed.
OTHER INFORMATION
OTHER INFORMATION Store at room temperature 15° - 30°C (59° -
86°F)
INACTIVE INGREDIENT
INACTIVE INGREDIENT purified water
PACKAGE PRINCIPAL DISPLAY PANEL
FIRST AID ONLY POVIDONE-IODINE PREP PAD
povidone-iodine patch
Acme United Corporation
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 9 24-8 110 (NDC:440 19 -8 11)
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0
7X4)
IODINE
10 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0 9 24-
8 110 -0 0
1 in 1 POUCH
0 7/26 /20 17
1
0 .45 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System
(syringe, patch, etc.)
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333A
0 7/24/20 17
LABELER -
Acme United Corporation (001180207)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Acme United Co rpo ratio n
0 459 24339
relabel(0 9 24-8 110 ) , repack(0 9 24-8 110 )
ESTAB