First Aid Only First Aid/burn Cream

First Aid Only First Aid/burn Cream
SPL v1
SPL
SPL Set ID 07245b54-b193-178e-e063-6394a90a2581
Route
TOPICAL
Published
Effective Date 2023-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5 mg)
Inactive Ingredients
Butylated Hydroxytoluene Cetostearyl Alcohol Dimethicone Glycerin Glyceryl Monostearate Isopropyl Myristate Water Edetate Sodium Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-16

Description

Benzalkonium chloride 0.13% Lidocaine HCL 0.5%

Purpose

First Aid Antiseptic External Analgesic


Medication Information

Purpose

First Aid Antiseptic

External Analgesic

Description

Benzalkonium chloride 0.13% Lidocaine HCL 0.5%

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor: cuts, •scrapes, •burns.

Section 51945-4

Carton Label

Warnings

For external use only.

Questions

1.800.835.2263

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



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

Other Information

Store at room temperature

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 0.5%

Inactive Ingredients

butylated hydroxytoluene, cetostearyl alcohol, dimethicone, edetate sodium, glycerin, glyceryl monostearate, isopropyl myristate, macrogol cetostearyl ether 20, methylcellulose, purified water, sodium methylparaben, sodium propylparaben

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

Keep Out of Reach of Children.

If swallowed, get medical help or 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 51945-4 (51945-4)

Carton Label

Purpose

First Aid Antiseptic

External Analgesic

Warnings

For external use only.

Questions

1.800.835.2263

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



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

Other Information

Store at room temperature

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 0.5%

Inactive Ingredients

butylated hydroxytoluene, cetostearyl alcohol, dimethicone, edetate sodium, glycerin, glyceryl monostearate, isopropyl myristate, macrogol cetostearyl ether 20, methylcellulose, purified water, sodium methylparaben, sodium propylparaben

Stop Use and Ask A Doctor If (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

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

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