POVIDONE-IODINE PREP PAD- povidone-iodine swab 
Foshan Flying Medical Products Co., Ltd.

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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POVIDONE-IODINE PREP PAD

Active ingredient

Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic

CAUTION: Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Indications and usage section

First aid to help prevent infection in minor cuts, scrapes, and burns

WARNINGS

For external use only. Flammable, keep away from fire or flame.

Do notuse

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

Directions

Apply product on the area 1-3 times daily and discard.

INACTIVE INGREDIENT

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

DRUG FACTS

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only. Flammable, keep away from fire or flame.

Do notuse

﹒in the eyes or apply over large areas of the body.

﹒on individuals who are allergic or sensitive to iodine.

Stop use

If irritation, redness or other symptoms develop.

Ask a doctor

If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.

CAUTION: Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply product on the area 1-3 times daily and discard.

Other information: Store at room temperature.

Inactive ingredients

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

image of carton

image of packet

POVIDONE-IODINE PREP PAD 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54429-0104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE9.43 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54429-0104-19.43 g in 1 POUCH; Type 0: Not a Combination Product01/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/15/2013
Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)
Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Flying Medical Products Co., Ltd.527021584manufacture(54429-0104)

Revised: 10/2018
Document Id: 77c95355-597b-418d-e053-2991aa0a61da
Set id: ad5abf95-d332-4afd-a344-9696edd43d63
Version: 5
Effective Time: 20181008
 
Foshan Flying Medical Products Co., Ltd.