First Aid Only First Aid-burn Cream

First Aid Only First Aid-burn Cream
SPL v4
SPL
SPL Set ID f31a44ff-e4ac-de1e-e053-2a95a90ab036
Route
TOPICAL
Published
Effective Date 2023-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Aloe Vera Leaf Alcohol Methylparaben Mineral Oil Paraffin Propylparaben Water Petrolatum White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-30

Description

Drug Facts

Purpose

First Aid Antiseptic External Analgesic


Medication Information

Purpose

First Aid Antiseptic

External Analgesic

Description

Drug Facts

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor

  • cuts
  • scrapes
  • burns.
Section 42229-5

Drug Facts

Section 51945-4

Packet Label

Warnings

For external use only

Directions
  • clean affected area
  • apply small amount 1-3 times daily
  • children under 2: consult doctor
Do Not Use
  • in the eyes
  • over large areas of the body
  • in large quantities, particularly over raw surfaces or blistered areas
  • if you are allergic to any of the ingredients
  • on deep puncture wounds, animal bites, or serious burns
  • more than one week unless directed by a doctor
Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients

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

Keep Out of Reach of Children

If swallowed contact a Poison Control Center right away.


Structured Label Content

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor

  • cuts
  • scrapes
  • burns.
Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Packet Label

Purpose

First Aid Antiseptic

External Analgesic

Warnings

For external use only

Directions
  • clean affected area
  • apply small amount 1-3 times daily
  • children under 2: consult doctor
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • in large quantities, particularly over raw surfaces or blistered areas
  • if you are allergic to any of the ingredients
  • on deep puncture wounds, animal bites, or serious burns
  • more than one week unless directed by a doctor
Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients (Inactive ingredients)

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

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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