CURE POVIDONE IODINE SWABSTICKS- povidone-iodine swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cure Medical LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Antiseptic  Use: Antiseptic skin preparation

Authorization status:

OTC monograph final

Summary of Product characteristics

CURE POVIDONE IODINE SWABSTICKS- POVIDONE-IODINE SWAB
CURE MEDICAL 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._
----------
Active Ingredient: Povidone-Iodine USP (10%)
Purpose: Antiseptic
Use: Antiseptic skin preparation
Warnings:
Do not use
if allergic to iodine
in the eyes
For external use only
Keep out of reach of children. In case of accidental ingestion, seek
professional assistance or consult a
poison control center immediately
Stop use and ask a doctor if
irritation or redness develops
condition persists for more than 72 hours
Apply product to skin as need
Other information
Not made with nature rubber latex
Not made with DEHP
For single use only
Inactive Ingredient
Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water
Cure Medical LLC
CURE POVIDONE IODINE SWABSTICKS
povidone-iodine swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7159 9 -0 0 2
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
0 .2 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
GLYCERIN (UNII: PDC6 A3C0 OX)
NO NO XYNO L-10 (UNII: K7O76 8 8 7AP)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:7159 9 -0 0 2-0 1
3 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 8 /0 5/20 18
2
NDC:7159 9 -0 0 2-0 2
1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 8 /0 5/20 18
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt333C
0 8 /0 5/20 18
LABELER -
Cure Medical LLC (070643426)
REGISTRANT -
Shaoxing Fuqing Health Products Co., Ltd. (530545003)
ESTABL