First Aid Only First Aid/burn Cream

First Aid Only First Aid/burn Cream
SPL v2
SPL
SPL Set ID caa67a05-bdbd-c380-e053-2995a90a0bf1
Route
TOPICAL
Published
Effective Date 2021-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5 mg)
Inactive Ingredients
Butylated Hydroxytoluene Ceteth-20 Cetostearyl Alcohol Dimethicone Glycerin Glyceryl Monostearate Isopropyl Myristate Methylcellulose (25 Mpa.s) Water Edetate Sodium Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-30
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 50566-9
  • Stop use and ask a doctor if ▪condition worsens or clears up and occurs again within a few days ▪symptoms persist for more than 7 days ▪a rash or allergic reaction occurs
Section 50570-1

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

Section 51945-4

carton label

Section 53413-1

Questions 1.800.835.2263

Warnings

For external use only.

Directions

Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily.

Children under 2- Consult a doctor

Other Information

Store in a cool dry area 150 – 250C (590 – 770F)

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients

butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium

Keep Out of Reach of Children.

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

Structured Label Content

Uses (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 50566-9 (50566-9)
  • Stop use and ask a doctor if ▪condition worsens or clears up and occurs again within a few days ▪symptoms persist for more than 7 days ▪a rash or allergic reaction occurs
Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

carton label

Section 53413-1 (53413-1)

Questions 1.800.835.2263

Purpose (PURPOSE)

First Aid Antiseptic

External analgesic

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)

Adults - Clean the affected area, apply a small amount of product (equal to the surface area of a fingertip) 1 to 3 times daily.

Children under 2- Consult a doctor

Other Information (OTHER INFORMATION)

Store in a cool dry area 150 – 250C (590 – 770F)

Active Ingredients (ACTIVE INGREDIENTS)

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients (INACTIVE INGREDIENTS)

butylated hydroxytoluene, ceteth-20, cetostearyl alcohol, dimethicone, glycerin, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, methyl paraben sodium, propylparaben sodium

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:26.836938 · Updated: 2026-03-14T23:05:11.503942