APLICARE POVIDONE-IODINE TRIPLES- povidone-iodine solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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 TRIPLES- 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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3101 APLICARE POVIDONE-IODINE TRIPLES
_ACTIVE INGREDIENT_
Povidone-iodine 10%
(equivalent to 1% available iodine)
_PURPOSE_
Antiseptic
_USE_
antiseptic skin preparation
_WARNINGS_
FOR EXTERNAL USE ONLY
AVOID POOLING BENEATH PATIENT
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 or puncture wounds
• serious burns
STOP USE AND ASK A DOCTOR IF
• infection occurs
• 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_
• 1% titratable iodine
• 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
MANUFACTURING INFORMATION
Manufactured for:
Medline industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Manufactured by:
Aplicare Products, LLC
550 Research Parkway, Merident, CT 06450 USA
1-800-633-5463
REF: APLS31015S
PACKAGE LABEL
APLICARE POVIDONE-IODINE TRIPLES
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-3101
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180S