FIRST AID DIRECT POVIDONE IODINE- povidone iodine antiseptic swab

First Aid Direct Povidone Iodine by

Drug Labeling and Warnings

First Aid Direct Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by CINTAS CORPORATION, JAMES ALEXANDER CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (each swab)

10% Povidone Iodine Solution USP (1% available iodine)

Purpose

Topical Antiseptic

Uses

To treat minor skin cuts, and abrasions

WARNINGS

FOR EXTERNAL USE ONLY

Ask a doctor before use if you have

• deep or puncture wounds
• serious burn

Stop use and ask doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs

Keep out of reach of children. 

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

Directions:

Reverse cardboard sleeve then crush at dot between thumb and forefinger.

Allow solution to saturate tip and apply solution to injury.

Other Information

Store at room temperature away from light keep from freezing or excessive heat

Inactive Ingredients

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions?

Call 1-908-362-9266 Monday through Friday 9:00 am - 5:00 pm e.s.t.

Package Label Principal Display Panel - Box of 10 Swabs

10 SWABS

(1/2 ml.)

UNIT NO. 

U1-16A

POVIDONE - IODINE SWABS U.S.P.

(ANTISEPTIC)

CONTAINS: POVIDONE IODINE 10%

EQUIVALENT TO 1% AVAILABLE IODINE

DISTRIBUTED BY

first aid direct

Mason, OH 45040

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT POVIDONE IODINE 
povidone iodine antiseptic swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-110-02	10 in 1 BOX	05/16/2022
1		10 mg in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/16/2022

Labeler - CINTAS CORPORATION (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
JAMES ALEXANDER CORP		040756421	manufacture(42961-110)