APLICARE POVIDONE-IODINE- povidone-iodine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aplicare Products, LLC

INN (International Name):

POVIDONE-IODINE

Composition:

IODINE 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic antiseptic skin preparation

Authorization status:

OTC monograph not final

Summary of Product characteristics

APLICARE POVIDONE-IODINE- 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._
----------
0001 POVIDONE-IODINE POUCH (STERILE)
_ACTIVE INGREDIENT_
Povidone-iodine USP 10%
_PURPOSE_
Antiseptic
_USE_
antiseptic skin preparation
_WARNINGS_
For external use only
Avoid pooling beneath patient
Avoid excessive heat. Stre at room temperature
DO NOT USE
• if allergic to iodine
• in the eyes
ASK DOCTOR BEFORE USE IF INJURIES ARE
• deep or 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 cas of accidental ingestion, seek professional assistance or
consult a poison control
center immediately.
_DIRECTIONS_
apply locally as needed
_OTHER INFORMATION_
• 1% titratable iodine
• 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 by:
Aplicare Products, LLC.
550 Research Parkway, Meriden,
CT 06450 USA
Made in USA
1-800-633-5463
0917
PACKAGE LABEL
APLICARE POVIDONE-IODINE
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52380-0001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Aplicare Products, LLC
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
10 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:52380-
0001-1
30 mL in 1 PACKET; Type 0: Not