Maximum Strength Betadine Clear Spray

SPL v2

SPL

SPL Set ID 31b94a76-1536-47c0-ab03-e487c2625c58

Route

TOPICAL

Published

Effective Date 2024-01-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 mg) Pramoxine (1 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Propylene Glycol Water Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-22

Description

Active ingredients Benzalkonium Cl 0.13% Pramoxine HCl 1.0%

Purpose

First aid Antiseptic Topical analgesic

Medication Information

Purpose

First aid Antiseptic

Topical analgesic

Description

Active ingredients Benzalkonium Cl 0.13% Pramoxine HCl 1.0%

Uses

First aid to help prevent infection and relieve pain or discomfort in minor

cuts
scrapes
burns

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 51945-4

Principal Display Panel

MAXIMUM STRENGTH

BETADINE® CLEAR

FIRST AID SPRAY

Pain Relieving

Antiseptic

Cleansing spray

Ideal for Minor Cuts, wounds, scrapes & Burns
Kills 99.9% of Germs* To prevent Infection
Maximum Strength Pain Relief
No Stinging or Burning

6 FL OZ (177 mL)

Dist. by: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA

www.betadine.com

*commonly associated with skin infections.

Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.

Warnings

For external use only

Directions

adults and children 2 years of age and older:
clean the affected area
spray a small amount of this product on the area 1 to 3 times daily
may be covered with sterile bandage
if bandaged, let dry first
children under 2 years of age:
consult a doctor

Do Not Use

in the eyes
over large areas of the body

Drug Facts

Active ingredients

Benzalkonium Cl 0.13%

Pramoxine HCl 1.0%

Other Information

protect from freezing

Inactive Ingredients

citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.

Stop Use and Ask A Doctor If

condition or symptoms get worse or last more than 1 week
Symptoms clear up and occur again within a few days

Ask A Doctor Before Use If You Have

deep or puncture wounds
serious burns
animal bites

Structured Label Content

Uses

First aid to help prevent infection and relieve pain or discomfort in minor

cuts
scrapes
burns

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 51945-4 (51945-4)

Principal Display Panel

MAXIMUM STRENGTH

BETADINE® CLEAR

FIRST AID SPRAY

Pain Relieving

Antiseptic

Cleansing spray

Ideal for Minor Cuts, wounds, scrapes & Burns
Kills 99.9% of Germs* To prevent Infection
Maximum Strength Pain Relief
No Stinging or Burning

6 FL OZ (177 mL)

Dist. by: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA

www.betadine.com

*commonly associated with skin infections.

Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.

Purpose

First aid Antiseptic

Topical analgesic

Warnings

For external use only

Directions

adults and children 2 years of age and older:
clean the affected area
spray a small amount of this product on the area 1 to 3 times daily
may be covered with sterile bandage
if bandaged, let dry first
children under 2 years of age:
consult a doctor

Do Not Use (Do not use)

in the eyes
over large areas of the body

Drug Facts

Active ingredients

Benzalkonium Cl 0.13%

Pramoxine HCl 1.0%

Other Information (Other information)

protect from freezing

Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.

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

condition or symptoms get worse or last more than 1 week
Symptoms clear up and occur again within a few days

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds
serious burns
animal bites

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid to help prevent infection and relieve pain or discomfort in minor cuts scrapes burns", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "51945-4": "Principal Display Panel MAXIMUM STRENGTH BETADINE® CLEAR FIRST AID SPRAY Pain Relieving Antiseptic Cleansing spray Ideal for Minor Cuts, wounds, scrapes & Burns Kills 99.9% of Germs* To prevent Infection Maximum Strength Pain Relief No Stinging or Burning 6 FL OZ (177 mL) Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA www.betadine.com ©2023 Atlantis Consumer Healthcare Inc. *commonly associated with skin infections. Tamper-Evident: Do not use if imprinted shrink band is broken or missing. Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.", "Purpose": "First aid Antiseptic Topical analgesic", "Warnings": "For external use only", "Directions": "adults and children 2 years of age and older: clean the affected area spray a small amount of this product on the area 1 to 3 times daily may be covered with sterile bandage if bandaged, let dry first children under 2 years of age: consult a doctor", "Do not use": "in the eyes over large areas of the body", "Drug Facts": "Active ingredients Benzalkonium Cl 0.13% Pramoxine HCl 1.0%", "Other information": "protect from freezing", "Inactive ingredients": "citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.", "Stop use and ask a doctor if": "condition or symptoms get worse or last more than 1 week Symptoms clear up and occur again within a few days", "Ask a doctor before use if you have": "deep or puncture wounds serious burns animal bites"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:33.857101 · Updated: 2026-03-14T23:09:25.529071