first aid antiseptic pain relieving cream

first aid antiseptic pain relieving cream
SPL v4
SPL
SPL Set ID 9cb3759a-35d9-4f6b-94ad-fafd4bc600bd
Route
topical
Published
Effective Date 2022-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
glyceryl monostearate glycerin water

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-11-01 Until 2027-04-01

Purpose

First aid antiseptic Pain relieving cream

Description

Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5%


Medication Information

Warnings

For external use only.

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

First aid antiseptic

Pain relieving cream

Other Information

Store at room temperature.

Inactive Ingredients

glycerin monostearate, glycerol, purified water

Description

Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5%

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

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
Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Package Labeling: 82996 002 01

Package Labeling: 82996 002 02

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

Warnings

For external use only.

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

First aid antiseptic

Pain relieving cream

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

glycerin monostearate, glycerol, purified water

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

directions (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
Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Package Labeling: 82996 002 01 (Package labeling: 82996-002-01)

Package Labeling: 82996 002 02 (Package labeling: 82996-002-02)

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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