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

Purpose

First Aid Antiseptic External Analgesic

Description

Benzalkonium chloride 0.13% Lidocaine HCL 0.5%


Medication Information

Warnings

For external use only.

Uses

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

Purpose

First Aid Antiseptic

External Analgesic

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 at room temperature

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

Description

Benzalkonium chloride 0.13% Lidocaine HCL 0.5%

Section 51945-4

Carton Label

Questions

1.800.835.2263

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

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 0.5%

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

Warnings

For external use only.

Uses

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

Purpose

First Aid Antiseptic

External Analgesic

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 at room temperature

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

Section 51945-4 (51945-4)

Carton Label

Questions

1.800.835.2263

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

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 0.5%

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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