MAXIMUM STRENGTH BETADINE CLEAR- benzalkonium cl and pramoxine hcl spray 
Atlantis Consumer Healthcare, Inc.

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MAXIMUM STRENGTH BETADINE CLEAR SPRAY

Drug Facts

Active ingredients

Benzalkonium Cl 0.13%

Pramoxine HCl 1.0%

Purpose

First aid Antiseptic

Topical analgesic

Uses

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

•
cuts
•
scrapes
•
burns

Warnings

For external use only

Do not use

•
in the eyes
•
over large areas of the body

Ask a doctor before use if you have

•
deep or puncture wounds
•
serious burns
•
animal bites

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

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

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

Other information

•
protect from freezing

Inactive ingredients

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

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.

MAXIMUM STRENGTH BETADINE® CLEAR SPRAY 6 OZ 177 ML
MAXIMUM STRENGTH BETADINE CLEAR 
benzalkonium cl and pramoxine hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-183
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-183-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00312/22/2023
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 1/2024
Document Id: 31b94a76-1536-47c0-ab03-e487c2625c58
Set id: 31b94a76-1536-47c0-ab03-e487c2625c58
Version: 1
Effective Time: 20240110
 
Atlantis Consumer Healthcare, Inc.