Burn Treatment

Burn Treatment
SPL v6
SPL
SPL Set ID 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40
Route
TOPICAL
Published
Effective Date 2016-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-06

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.

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

Other Information

Store at room temperature

Package Labeling:

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 Reah 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 • 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.

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

Other Information (Other information)

Store at room temperature

Package Labeling:

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 Reah of Children. (Keep out of reah 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 • serious burns.


Advanced Ingredient Data


Raw Label Data

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