POVIDONE-IODINE SOLUTION- povidone-iodine solution
Tongzhou Ruihong Medical Products Factory

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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Drug Fact

Active Ingredient

POVIDONE-IODINE USP 10%

Purpose

Antiseptic

Warnings

Do not use if allergic to iodine.

For External use only.

Ask a doctor before use if injuries are

--Deep or puncture wounds

--serious bums

stop use ask a doctor if

--reness ,irritation ,swelling or pain persists or increases

--infection occurs

Do not use in eyes

Avoid "pooling "benesth patient.Prolonged exposure to wet solution may cause skin irrtation.

Keep out of reach of children.

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

Directions

Apple locally as needed.

Other information

--1% titrarabil iodine --latex free ---for hospital or professional use only

Use

Antiseptic skin preparation

Inactive Ingredients

citric acid,disodium,phosphate,nonoxynol-9,sodium hydrexide,Water

label

POVIDONE-IODINE SOLUTION
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58488-006
Route of Administration	PERCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.01 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58488-006-01	1201 g in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	05/20/2014

Labeler - Tongzhou Ruihong Medical Products Factory (421312726)

Name	Address	ID/FEI	Business Operations
Establishment
Tongzhou Ruihong Medical Products Factory		421312726	manufacture(58488-006)