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Maximum Strength Betadine Clear drug information

BENZALKONIUM CL AND PRAMOXINE HCL
Atlantis Consumer Healthcare, Inc. · TOPICAL

Product NDC: 67618-183

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameBENZALKONIUM CL AND PRAMOXINE HCL
Labeler / manufacturerAtlantis Consumer Healthcare, Inc.
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC67618-183
Label effective date2026-08-31

Official product label reference

Maximum Strength Betadine Clear — Atlantis Consumer Healthcare, Inc.

This page contains 11 source sections for BENZALKONIUM CL AND PRAMOXINE HCL, topical route. Label set 31b94a76-1536-47c0-ab03-e487c2625c58, version 3.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses First aid to help prevent infection and relieve pain or discomfort in minor • cuts • scrapes • burns

Purpose

Purpose First aid Antiseptic Topical analgesic
Dosage and administration — label text
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
Warnings
Warnings For external use only
Active ingredient
Drug Facts Active ingredients Benzalkonium Cl 0.13% Pramoxine HCl 1.0%
Do not use
Do not use • in the eyes • over large areas of the body
Ask a doctor before use
Ask a doctor before use if you have • deep or puncture wounds • serious burns • animal bites
When to stop use and seek help
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
Child safety
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Storage and handling
Other information • protect from freezing
Inactive ingredient
Inactive ingredients citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.

Official sources and product identifiers

Substances listed: BENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDE

Package NDC codes

67618-183-06

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.