First Aid Antiseptic Pain Relieving Cream Benzalkonium Chloride Lidocaine Hydrochloride

First Aid Antiseptic Pain Relieving Cream Benzalkonium Chloride Lidocaine Hydrochloride
SPL v1
SPL
SPL Set ID 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d
Route
TOPICAL
Published
Effective Date 2024-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-15

Description

Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic  Pain relieving cream


Medication Information

Purpose

First aid antiseptic 

Pain relieving cream

Description

Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5%

Uses
  • First aid to help prevent infection in minor cuts scrapes and burns.
  • For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.
Warnings

For external use only. 

Question?

+1(855)924-2182

Directions
  • clean the affected area.
  • Adults and children 2 years of age and older. Apply a small amount of this product to affected area not more than 3 times daily.
  • Children under 2 years of age consult a doctor.
  • May be covered with a sterile bandage.
Do Not Use
  • in the eyes
  • over large areas of the body
  • in large quantities 
  • over raw surfaces or blistered areas 
  • longer than 1 week unless directed by a doctor.
Drug Facts

84219 002 00

Other Information

Store at room temperature.

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Inactive Ingredients

glycerin monostearate, glycerol, purified water

Stop Use and Ask A Doctor If
  • the condition persists or gets worse.
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have
  • animal bites
  • deep or puncture wounds 
  • serious burns

Structured Label Content

Uses
  • First aid to help prevent infection in minor cuts scrapes and burns.
  • For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.
Purpose

First aid antiseptic 

Pain relieving cream

Warnings

For external use only. 

Question?

+1(855)924-2182

Directions
  • clean the affected area.
  • Adults and children 2 years of age and older. Apply a small amount of this product to affected area not more than 3 times daily.
  • Children under 2 years of age consult a doctor.
  • May be covered with a sterile bandage.
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • in large quantities 
  • over raw surfaces or blistered areas 
  • longer than 1 week unless directed by a doctor.
Drug Facts

84219 002 00 (84219-002-00)

Other Information (Other information)

Store at room temperature.

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Inactive Ingredients (Inactive ingredients)

glycerin monostearate, glycerol, purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse.
  • symptoms persist for more than 7 days or clear up and occur again within a few 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • animal bites
  • deep or puncture wounds 
  • serious burns

Advanced Ingredient Data


Raw Label Data

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