Astonea Burn Cream

Astonea Burn Cream
SPL v1
SPL
SPL Set ID fbd4a1c0-6036-cc8f-e053-6394a90a1e91
Route
TOPICAL
Published
Effective Date 2023-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.5 g)
Inactive Ingredients
Aloe Vera Leaf Cetostearyl Alcohol Edetate Disodium Anhydrous Ethylhexylglycerin Glyceryl Stearate/peg-100 Stearate Maltodextrin Phenoxyethanol Glycerin Water Mineral Oil Propylene Glycol Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-05-16

Description

Lidocaine HCL 0.5% Topical Analgesic Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

Topical Analgesic Topical Antiseptic


Medication Information

Purpose

Topical Analgesic

Topical Antiseptic

Description

Lidocaine HCL 0.5% Topical Analgesic Benzalkonium Chloride 0.13% Topical Antiseptic

Uses

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts
  • Scrapes
Stop Use

•the condition gets worse •condition clears up and recurs within a few days •condition persists for more than 7 days

Warnings

FOR EXTERNAL USE ONLY

Directions

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 or 4 times daily.
  • may be covered with a sterile bandage

Children under 2 years

  • consult a doctor
Do Not Use

Do Not Use:

  • In the eyes
  • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
  • In large quantities, particularly over raw surfaces or blistered areas.
Other Information

•store in a cool, dry area 59°-86°F (15°-30°C) •tamper evident sealed packets do not use any opened or torn packets

Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Inactive Ingredients

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.

Principal Display Panel

If Pregnant Or Breast Feeding

ask a health care professional before use.

Keep Out of Reach of Children

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


Structured Label Content

Uses

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts
  • Scrapes
Purpose

Topical Analgesic

Topical Antiseptic

Stop Use

•the condition gets worse •condition clears up and recurs within a few days •condition persists for more than 7 days

Warnings

FOR EXTERNAL USE ONLY

Directions

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 or 4 times daily.
  • may be covered with a sterile bandage

Children under 2 years

  • consult a doctor
Do Not Use

Do Not Use:

  • In the eyes
  • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
  • In large quantities, particularly over raw surfaces or blistered areas.
Other Information

•store in a cool, dry area 59°-86°F (15°-30°C) •tamper evident sealed packets do not use any opened or torn packets

Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.

Principal Display Panel

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health care professional before use.

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.


Advanced Ingredient Data


Raw Label Data

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