APLICARE POVIDONE-IODINE PREP PAD- povidone-iodine solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aplicare Products, LLC

Podání:

TOPICAL

Druh předpisu:

OTC DRUG

Terapeutické indikace:

Antiseptic antiseptic skin preparation

Stav Autorizace:

OTC monograph not final

Charakteristika produktu

APLICARE POVIDONE-IODINE PREP PAD- POVIDONE-IODINE SOLUTION
APLICARE PRODUCTS, 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._
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4111 APLICARE POVIDONE-IODINE PREP PAD
_ACTIVE INGREDIENT_
Povidone-iodine USP 10%
_PURPOSE_
Antiseptic
_USE_
antiseptic skin preparation
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
if allergic to iodine or in the eyes
ASK A DOCTOR BEFORE USE
if injuries are deep wounds, puncture wounds, or serious burns
STOP USE AND ASK A DOCTOR
if infection occurs or if redness, irritation, swelling or pain
persists or increases
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
consult a poison
control center immediately.
_DIRECTIONS_
apply locally as needed
_OTHER INFORMATION_
Prep pad size: 1-1/4" × 1-1/2"
1% titratable iodine
not made with natural rubber latex
for hospital or professional use only
avoid excessive heat - store at room temperature
_INACTIVE INGREDIENTS_
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
MANUFACTURING INFORMATION
Manufactured by:
Aplicare Products, LLC
550 Research Pkwy, Meriden CT 06450 USA
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA with domestic and foreign materials
1-800-633-5463
RF18APL
REF: APLP1111
PACKAGE LABEL
APLICARE POVIDONE-IODINE PREP PAD
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-4111
ROUTE OF ADMINISTRATION
TOPICAL
Aplicare Products, LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
10 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 29