POVIDONE-IODINE PREP- povidone-iodine swab

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Acme United Corporation

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

First aid antiseptic to help prevent skin infection

authorization_status:

OTC monograph not final

SPC

POVIDONE-IODINE PREP- POVIDONE-IODINE SWAB
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._
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FIRST AID ONLY POVIDONE-IODINE PREP PAD
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Povidone Iodine 10%
_PURPOSE_
Antiseptic
_USE_
First aid antiseptic to help prevent skin infection
_WARNINGS_
For external use only
DO NOT USE
• in eyes • over large areas of the body • if allergic to any of
the ingredients • longer than 1 week unless
directed by a doctor
ASK DOCTOR BEFORE USE IF YOU HAVE
• deep or puncture wounds • animal bites • serious burns
STOP USE AND ASK A DOCTOR IF
• conditions worsen or clear up and then recur • the condition
persists for more than 7 days
KEEP OUT OF THE REACH OF CHILDREN.
If swallowed get medical help or contact a Poison Control Center right
away.
_DIRECTIONS_
Open packet and wipe affected area. Apply 1 to 3 times daily. May be
covered with a sterile bandage. If
bandaged, let dry first.
_OTHER INFORMATION_
Store at room temperature
_INACTIVE INGREDIENTS_
alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose,
nonoxynol-10, potassium iodide, purified
water, sodium hydroxide
PACKAGE LABELING:
POVIDONE-IODINE PREP
povidone-iodine swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 9 24-8 111(NDC:59 0 50 -0 6 0 )
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 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
GLYCERIN (UNII: PDC6 A3C0 OX)
NO NO XYNO L-10 (UNII: K7O76 8 8 7AP)
PO TASSIUM IO DIDE (UNII: 1C4QK22F9 J)
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:0