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.

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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

image description

CURE POVIDONE IODINE SWABSTICKS
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71599-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.2 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71599-002-01	3 in 1 POUCH; Type 0: Not a Combination Product	08/05/2018
2	NDC:71599-002-02	1 in 1 POUCH; Type 0: Not a Combination Product	08/05/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	08/05/2018

Labeler - Cure Medical LLC (070643426)

Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)

Name	Address	ID/FEI	Business Operations
Establishment
Shaoxing Fuqing Health Products Co., Ltd.		530545003	manufacture(71599-002)