genuine first aid first aid antiseptic pain relieving cream

genuine first aid first aid antiseptic pain relieving cream
SPL v3
SPL
SPL Set ID af08c8f7-8761-ee3f-e053-2995a90a9677
Route
topical
Published
Effective Date 2020-09-04
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 2020-01-01

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 with minorburns, minorcuts, and scrapes.
Purpose

First aid antiseptic

Pain relieving cream

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.
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 listed areas
  • longer than 1 week unless directed by a doctor
Drug Facts

Package Labeling:

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Stop Use and Ask A Doctor If
  • the condition persists or gets worse
  • symptoms persists for more than 7 days or clearup and occurs again with in 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
  • animals 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 with minorburns, minorcuts, and scrapes.
Purpose

First aid antiseptic

Pain relieving cream

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.
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 listed areas
  • longer than 1 week unless directed by a doctor
Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse
  • symptoms persists for more than 7 days or clearup and occurs again with in 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)
  • animals bites
  • deep or puncture wounds
  • serious burns.

Advanced Ingredient Data


Raw Label Data

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