CURE POVIDONE IODINE SWABSTICKS- povidone-iodine swab

Cure Povidone Iodine Swabsticks by

Drug Labeling and Warnings

Cure Povidone Iodine Swabsticks by is a Otc medication manufactured, distributed, or labeled by Cure Medical LLC, Shaoxing Fuqing Health Products Co., Ltd., Shaoxing Fuqing Health Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Povidone-Iodine USP (10%)

PURPOSE

Purpose: Antiseptic 

INDICATIONS & USAGE

Use: Antiseptic skin preparation

WARNINGS

Warnings:

Do not use

• if allergic to iodine
• in the eyes

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

ASK DOCTOR

Stop use and ask a doctor if

• irritation or redness develops
• condition persists for more than 72 hours

DOSAGE & ADMINISTRATION

Apply product to skin as need

OTHER SAFETY INFORMATION

Other information

• Not made with nature rubber latex
• Not made with DEHP
• For single use only

INACTIVE INGREDIENT

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURE POVIDONE IODINE SWABSTICKS 
povidone-iodine swab

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/05/2018

Labeler - Cure Medical LLC (070643426)

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

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