First Aid Only First Aid/burn Cream

First Aid Only First Aid/burn Cream
SPL v2
SPL
SPL Set ID 860d767d-63b9-127a-e053-2a91aa0a3f12
Route
TOPICAL
Published
Effective Date 2019-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.5 g)
Inactive Ingredients
Aloe Vera Leaf Water Propylparaben Glyceryl Monostearate Edetate Disodium Light Mineral Oil Stearic Acid Peg-100 Stearate Cetyl Alcohol Trolamine Glycerin Methylparaben Propylene Glycol Diazolidinyl Urea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-04-08

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 Image

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

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

Questions?

1-800-835-2263

Other Information

Store at room temperature

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients

aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, triethanolamine

When Using This Product

avoid contact with eyes

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

Keep Out of the Reach of Children.

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

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns


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 Image

Purpose

First Aid antiseptic

External analgesic

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

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

Questions?

1-800-835-2263

Other Information (Other information)

Store at room temperature

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients (Inactive ingredients)

aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, triethanolamine

When Using This Product (When using this product)

avoid contact with eyes

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

▪a rash or allergic reaction occurs

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

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites, or serious burns


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)