First Aid Burn Cream

First Aid Burn Cream
SPL v5
SPL
SPL Set ID 25ebf112-8ac3-4402-9a87-00e454ab7efa
Route
TOPICAL
Published
Effective Date 2013-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-04-20

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

Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
  •     clean the affected area
  •     apply a small amount of this product on the area 1 to 3 times daily
  •     may be covered with a sterile bandage
  •     children under 2 years of age: consult a doctor

Do Not Use
  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas

Questions?

800-275-3433   [email protected]   www.waterjel.com

Other Information
  • store at room temperature (do not freeze)

  • tamper evident sealed packets
  • do not use if packet is opened or torn
  • you may report a serious reaction to this product to 800-275-3433

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl  0.5%



Inactive Ingredients

water, mineral oil, stearic acid, glyceryl stearate se, glycerin, Peg-100, cetyl alcohol, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, aloe barbadensis leaf juice, triethanolamine, disodium EDTA

Principal Display Panel

When Using This Product

avoid contact with eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

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

Purpose

First Aid antiseptic

External analgesic



Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
  •     clean the affected area
  •     apply a small amount of this product on the area 1 to 3 times daily
  •     may be covered with a sterile bandage
  •     children under 2 years of age: consult a doctor

Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas

Questions?

800-275-3433   [email protected]   www.waterjel.com

Other Information (Other information)
  • store at room temperature (do not freeze)

  • tamper evident sealed packets
  • do not use if packet is opened or torn
  • you may report a serious reaction to this product to 800-275-3433

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13%

Lidocaine HCl  0.5%



Inactive Ingredients (Inactive ingredients)

water, mineral oil, stearic acid, glyceryl stearate se, glycerin, Peg-100, cetyl alcohol, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, aloe barbadensis leaf juice, triethanolamine, disodium EDTA

Principal Display Panel

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
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

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

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