A+ Health- Povidone-iodine Topical Solution

A+ Health- Povidone-iodine Topical Solution
SPL v1
SPL
SPL Set ID 3e63514a-dbb8-5bef-e063-6294a90a4008
Route
TOPICAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Water Nonoxynol-9 Sodium Hydroxide Glycerin Citric Acid Sodium Phosphate, Dibasic, Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-06

Description

Active ingredient Povidone-iodine, 10% (1% available iodine)

Purpose

First aid antiseptic


Medication Information

Purpose

First aid antiseptic

Description

Active ingredient Povidone-iodine, 10% (1% available iodine)

Uses

first aid to help prevent infection in minor • cuts • scrapes • burns

Section 42229-5

Manufactured for:

Bionpharma Inc.,

Princeton, NJ 08540

**This product is not manufactured or dislributed by the owners of Betadine ®

L0001034

R0425

Warnings

For exmrnal use only

Directions

• clean the affected area

• apply a small amount of product to the area 1 to 3 times daily

• may be covered with a sterile bandage • it bandaged, let dry first

Do Not Use

• in the eyes • over large areas of the body

Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Other Information

• store at 20°-25°C (68°-77°F)

Inactive Ingredients

citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water and sodium hydroxide

Questions Or Comments?

1-888-235-2466

8 Fl Oz (237 Ml) Bottle

** compare to the active ingredient in Betadine ®

a+ health TM

first aid

antiseptic

povidone-

iodine 10%

topical solution USP

• helps prevent infection

in minor cuts, scrapes & burns

8 fl oz (237 mL)

Ask A Doctor Before Use

in case of deep or puncture wounds, animal bites, or serious burns

Stop Use and Ask A Doctor If

• the condition persists or gets worse • you need to use this product for more than 1 week

Keep Out of Reach of Children.

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


Structured Label Content

Uses

first aid to help prevent infection in minor • cuts • scrapes • burns

Section 42229-5 (42229-5)

Manufactured for:

Bionpharma Inc.,

Princeton, NJ 08540

**This product is not manufactured or dislributed by the owners of Betadine ®

L0001034

R0425

Purpose

First aid antiseptic

Warnings

For exmrnal use only

Directions

• clean the affected area

• apply a small amount of product to the area 1 to 3 times daily

• may be covered with a sterile bandage • it bandaged, let dry first

Do Not Use (Do not use)

• in the eyes • over large areas of the body

Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Other Information (Other information)

• store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water and sodium hydroxide

Questions Or Comments? (Questions or comments?)

1-888-235-2466

8 Fl Oz (237 Ml) Bottle (8 fl oz (237 mL) Bottle)

** compare to the active ingredient in Betadine ®

a+ health TM

first aid

antiseptic

povidone-

iodine 10%

topical solution USP

• helps prevent infection

in minor cuts, scrapes & burns

8 fl oz (237 mL)

Ask A Doctor Before Use (Ask a doctor before use)

in case of deep or puncture wounds, animal bites, or serious burns

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• the condition persists or gets worse • you need to use this product for more than 1 week

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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