FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES- povidone-iodine liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

The Wild Side, Llc dba Firstline Medical

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - Patient preoperative skin preparation - For preparation of the skin prior to surgery - Helps to reduce bacteria that potentially can cause skin infection

Authorization status:

OTC monograph not final

Summary of Product characteristics

FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES -
POVIDONE-IODINE LIQUID
THE WILD SIDE, LLC DBA FIRSTLINE MEDICAL
_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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FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES
FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES
ACTIVE INGREDIENT
Povidone-iodine 10%
PURPOS E
Antiseptic
US ES
Patient preoperative skin preparation
For preparation of the skin prior to surgery
Helps to reduce bacteria that potentially can cause skin infection
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE
in the eyes
WHEN USING THIS PRODUCT
keep out of eyes, ears, and mouth
STOP USE AND ASK A DOCTOR IF
irritation and redness develop
condition persists for more than 72 hours
infection occurs
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
clean the area
reverse cardboard sleeve then crush at dot between thumb and
forefinger
allow solution to saturate tip
apply product to the operative site prior to surgery using the
applicator tip
OTHER INFORMATION
Store at room temperature away from light
Keep from freezing or excessive heat
INACTIVE INGREDIENTS
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
QUES TIONS ?
call 1-866-433-2131 Monday through Friday 9:00am-5:00pm est
LINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC AMPULES 25 COUNT
(41477-420-69)
Representative Package Labeling
FIRSTLINE MEDICAL THE I-STICK POVIDONE-IODINE ANTISEPTIC
AMPULES
povidone-iodine liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:41477-420
The Wild Side, Llc dba Firstline Medical
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0
7X4)
IODINE
10 0 mg in 1 mL
INACTIVE IN