MAXIMUM STRENGTH BETADINE CLEAR- benzalkonium cl and pramoxine hcl spray

Maximum Strength Betadine Clear by

Drug Labeling and Warnings

Maximum Strength Betadine Clear by is a Otc medication manufactured, distributed, or labeled by Atlantis Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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.

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH BETADINE CLEAR 
benzalkonium cl and pramoxine hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-183-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	12/22/2023

Labeler - Atlantis Consumer Healthcare, Inc. (118983925)