APLICARE POVIDONE-IODINE SCRUB- povidone-iodine scrub solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
15-12-2022

Aktivna sestavina:

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

Dostopno od:

Aplicare Products, LLC

Pot uporabe:

TOPICAL

Tip zastaranja:

OTC DRUG

Terapevtske indikacije:

Antiseptic Antiseptic skin preparation

Status dovoljenje:

OTC monograph not final

Lastnosti izdelka

                                APLICARE POVIDONE-IODINE SCRUB- POVIDONE-IODINE SCRUB 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._
----------
0024 APLICARE POVIDONE-IODINE SCRUB
_ACTIVE INGREDIENT_
Povidone-iodine 10%
_PURPOSE_
Antiseptic
_USE_
Antiseptic skin preparation
_WARNINGS_
FOR EXTERNAL USE ONLY
AVOID POOLING BENEATH THE PATIENT. Prolonged exposure to wet solution
may cause
skin irritation.
AVOID EXCESSIVE HEAT. Store at room temperature.
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
DO NOT USE
if allergic to iodine
in the eyes
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
consult a poison control
center immediately.
_DIRECTIONS_
use sponges to prep desired area
_OTHER INFORMATION_
for single use only
not made with natural rubber latex
for hospital or professiona use only
_QUESTIONS OR COMMENTS?_
800 633 5463
_INACTIVE INGREDIENTS_
ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate,
nonoxynol-9, sodium
hydroxide, water
MANUFACTURING INFORMATION
Manufactured by:
Aplicare Products, LLC
550 Research Pkwy, Meriden, CT 06450 USA
Made in USA with domestic and foreign materials
1-800-633-5463
REF: ORF22025S
RD18APL
PACKAGE LABEL
Aplicare Products, LLC
APLICARE POVIDONE-IODINE SCRUB
povidone-iodine scrub solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-0024
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
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXY
                                
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