71729-019-01, 03 medi-first plus

71729-019-01, 03 medi-first plus
SPL v2
SPL
SPL Set ID f522fb0b-3d86-b228-e053-2a95a90a55e9
Route
topical
Published
Effective Date 2025-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (5 mg)
Inactive Ingredients
ethylhexylglycerin maltodextrin aloe vera leaf glyceryl monostearate water glycerin mineral oil peg-100 stearate phenoxyethanol propylene glycol trolamine stearic acid cetostearyl alcohol edetate disodium anhydrous

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-03
Purpose

First aid antiseptic Topical analgesic

Description

Benzalkonium Chloride 0.13% Lidocaine HCI 0.5%

Medication Information

Warnings

For external use only.

Uses
  • for the temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Purpose

First aid antiseptic

Topical analgesic

Directions
  • Adults and children 2 years and over:clean the affected area, apply a small amount not more than 3 to 4 times daily
  • Children under 2 years:do not use, consult a doctor

(continued on next panel)

Other Information
  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

aloe barbadensis leaf juice, cetearyl alcohol,disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol, purified water, PEG-100 stearate,phenoxyethanol, stearic acid, triethanolamine

Description

Benzalkonium Chloride 0.13% Lidocaine HCI 0.5%

Do Not Use
  • in the eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Questions Or Comments?

800-634-7680

Stop Use and Ask A Doctor If
  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

If ingested, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only.

Uses
  • for the temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Purpose

First aid antiseptic

Topical analgesic

Directions
  • Adults and children 2 years and over:clean the affected area, apply a small amount not more than 3 to 4 times daily
  • Children under 2 years:do not use, consult a doctor

(continued on next panel)

Other Information (Other information)
  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, cetearyl alcohol,disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol, purified water, PEG-100 stearate,phenoxyethanol, stearic acid, triethanolamine

Do Not Use (Do not use)
  • in the eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

Active Ingredients (Active ingredients)

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Questions Or Comments? (Questions or comments?)

800-634-7680

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:55.466366 · Updated: 2026-03-14T23:09:59.416921