PSP Iodine tincture BP 2.5% first aid antiseptic

PSP Iodine tincture BP 2.5 first aid antiseptic by

Drug Labeling and Warnings

PSP Iodine tincture BP 2.5 first aid antiseptic by is a Otc medication manufactured, distributed, or labeled by RW Consumer Products Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PSP IODINE TINCTURE BP 2.5 FIRST AID ANTISEPTIC- iodine, potassium iodide solution 
RW Consumer Products 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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PSP Iodine tincture BP 2.5% first aid antiseptic

Drug Facts

Active ingredient

Iodine 2.5%

Potassium Iodide 2.5%

Purpose

First Aid Antiseptic

Use

• first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Warnings

For external use only.

Do not use

• in the eyes or apply over large areas of the body
• longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds animal bites serious burns

Stop use and ask a doctor if

• the condition persists or gets worse

Keep out of reach of children.

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

Directions

Clean the affected area Apply a small amount of this product on the area 1 to 3 times daily May be covered with a sterile bandage If bandaged, let dry first

Other Information

• Store in a cool, dark place
• Do not use if shrink band around cap is broken or missing

Inactive ingredients

Ethyl alcohol, purified water

Package Labeling:

PSP IODINE TINCTURE BP 2.5 FIRST AID ANTISEPTIC 
iodine, potassium iodide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69612-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	25 mg  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69612-019-01	1 in 1 BOX	10/01/2021	10/01/2021
1		50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2021	10/01/2021

Labeler - RW Consumer Products Ltd (245592118)

Revised: 6/2022

Document Id: e0e17b29-8567-e02b-e053-2995a90a3492

34390-5

Set id: cba71f0f-b3f9-60e6-e053-2995a90a86cf

Version: 2

Effective Time: 20220607