Globe First Aid Burn Cream

Globe First Aid Burn Cream
SPL v4
SPL
SPL Set ID 087ac43c-1076-d1e2-e063-6294a90a5859
Route
TOPICAL
Published
Effective Date 2023-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.005 g)
Inactive Ingredients
Water Edetate Disodium Propylene Glycol Aloe Vera Leaf Mineral Oil Stearic Acid Glycerin Trolamine Glyceryl Mono And Dipalmitostearate Diazolidinyl Urea Methylparaben Cetyl Alcohol Peg-100 Stearate Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-23

Description

Lidocaine HCL 0.5%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine HCL 0.5%

Uses

Temporary Relief of pain associated with minor cuts, scrapes and burns.

Helps protect against harmful bacteria.

Section 55106-9

Benzalkonium Chloride 0.13%

Warnings

For external Use Only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Questions

Call: 1-888-296-9067

Directions
  • Clean the affected area
  • Apply a small amount not more than 3 times daily
  • May be covered with a sterile bandage
Package Label

Active Ingredient

Lidocaine HCL 0.5%

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Storage Information

  • Store in cool dry area 15° to 25°C (59° to 77°F).
  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Keep Out of Reach of Children

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


Structured Label Content

Uses

Temporary Relief of pain associated with minor cuts, scrapes and burns.

Helps protect against harmful bacteria.

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%

Purpose

Topical Analgesic

Warnings

For external Use Only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Questions

Call: 1-888-296-9067

Directions
  • Clean the affected area
  • Apply a small amount not more than 3 times daily
  • May be covered with a sterile bandage
Package Label

Active Ingredient

Lidocaine HCL 0.5%

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Storage Information

  • Store in cool dry area 15° to 25°C (59° to 77°F).
  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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