APLICARE POVIDONE-IODINE PAINT- povidone-iodine solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aplicare Products, LLC

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Antiseptic antiseptic skin preparation

Autorisasjon status:

OTC monograph not final

Preparatomtale

APLICARE POVIDONE-IODINE PAINT- 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._
----------
0101 APLICARE POVIDONE-IODINE PAINT
_ACTIVE INGREDIENT_
Povidone-iodine USP 10%
_PURPOSE_
Antiseptic
_USE_
antiseptic skin preparation
_WARNINGS_
FOR EXTERNAL USE ONLY
AVOID POOLING BENEATH PATIENT. Prolonged exposure to wet solution may
cause skin
irritation.
AVOID EXCESSIVE HEAT. Store at room temperature.
DO NOT USE
if allergic to iodine
in the eyes
ASK A DOCTOR BEFORE USE IF INJURIES ARE
deep wounds
puncture wounds
serious burns
STOP USE AND ASK A DOCTOR IF
redness, irritation, swelling or pain persists or increases
infection occurs
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
consult a poison control
center immediately.
_DIRECTIONS_
use sponge sticks to prep desired area
_OTHER INFORMATION_
for single use only
not made with natural rubber latex
for hospital or professional use only
_INACTIVE INGREDIENTS_
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
PACKAGE LABEL
APLICARE POVIDONE-IODINE PAINT
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-0101
ROUTE OF ADMINISTRATION
TOPICAL
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
Aplicare Products, LLC
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:52380-
0101-5
2 in 1 PACKAGE
03/01/1992
07/31/2025
1
52.5 mL in 1 APPLICATOR; Type 0: Not a
Combination Product
MARKETING INFO