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First Aid Antiseptic — v11

First Aid Antiseptic

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Version

v11

Effective date

September 26, 2025

Original packager

Yes

Sections captured

Identifiers

Document ID: 3fb8db85-d35b-f29d-e063-6394a90ada37
Set ID: b1c71ff1-8ffa-46df-9b43-86ed062c3a98
Application numbers: M003
Product NDCs: 0363-0777
Package NDCs: 0363-0777-34
Original packager NDCs: —

Names & Manufacturers

Brand names: First Aid Antiseptic
Generic names: POVIDONE-IODINE
Manufacturer names: Walgreens
Product types: HUMAN OTC DRUG

Substances & Pharmacology

Substance names: POVIDONE-IODINE
Routes: TOPICAL
Pharmacologic class (PE): —
Pharmacologic class (EPC): Antiseptic [EPC]
Pharmacologic class (CS): Iodine [CS]
Mechanism of action: —

Other identifiers

NUI: M0011640, N0000175486
RxCUI: 312564
UNII: 85H0HZU99M
UPC: —

Structured Label Sections

Active Ingredient (1)

Sequence 1

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

Adverse Reactions (1)

Sequence 1

Ask Doctor (1)

Sequence 1

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Do Not Use (1)

Sequence 1

Do not use in the eyes or apply over large areas of the body longer than 1 week unless directed by a doctor

Dosage And Administration (1)

Sequence 1

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

Inactive Ingredient (1)

Sequence 1

inactive ingredients C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

Indications And Usage (1)

Sequence 1

Use first aid to help prevent the risk of infection in: minor cuts scrapes burns

Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (1)

Sequence 1

principal display panel Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredient in Betadine ® Solution‡ 10% Povidone-Iodine Solution FIRST AID ANTISEPTIC Helps kill germs & prevent infection from minor burns, cuts & scrapes 8 FL OZ (236 mL) image description

Purpose (1)

Sequence 1

Purpose First aid antiseptic

Questions (1)

Sequence 1

Questions? 1-888-593-0593

Spl Product Data Elements (1)

Sequence 1

First Aid Antiseptic POVIDONE-IODINE C12-13 PARETH-9 CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS GLYCERIN SODIUM HYDROXIDE WATER POVIDONE-IODINE IODINE

Spl Unclassified Section (3)

Sequence 1

Other information store between 15°-30° C (59°-86F)

Sequence 2

Claims Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.

Sequence 3

Disclaimer ‡This product or is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Betadine .

Stop Use (1)

Sequence 1

Stop use and ask a doctor if condition persists or gets worse

Warnings (1)

Sequence 1

Warnings For external use only

OpenFDA raw payload

{'application_number': ['M003'],
 'brand_name': ['First Aid Antiseptic'],
 'generic_name': ['POVIDONE-IODINE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Walgreens'],
 'nui': ['N0000175486', 'M0011640'],
 'package_ndc': ['0363-0777-34'],
 'pharm_class_cs': ['Iodine [CS]'],
 'pharm_class_epc': ['Antiseptic [EPC]'],
 'product_ndc': ['0363-0777'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['312564'],
 'spl_id': ['3fb8db85-d35b-f29d-e063-6394a90ada37'],
 'spl_set_id': ['b1c71ff1-8ffa-46df-9b43-86ed062c3a98'],
 'substance_name': ['POVIDONE-IODINE'],
 'unii': ['85H0HZU99M']}