First Aid
FDA Label NDC 69103-3553

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical for the product First Aid (NDC 69103-3553). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, do not use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Gram)

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

  • temporary relief of pain associated with minor burns, cuts and scrapes
  • helps protect against harmful bacteria

Warnings

For external use only

Do Not Use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children If ingested contact a Poison Control Center right away.

Directions

  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage.

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Manufactured for:
Provision Medical Products
Palm Desert, CA 92211

Principal Display Panel - Pouch Label

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

cream Relieves Pain and Helps Prevent Infection

First Aid and Burn 0.9g

The Provision
First Aid
Line™

Principal Display Panel (Pouch Label)

Principal Display Panel (Pouch Label)

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