globe first aid burn cream

globe first aid burn cream
SPL v1
SPL
SPL Set ID 1308ce91-2858-310a-e063-6394a90a6810
Route
topical
Published
Effective Date 2024-03-06
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 cetostearyl alcohol maltodextrin glyceryl stearate/peg-100 stearate phenoxyethanol ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-06

Purpose

Topical Analgesic

Description

Lidocaine HCL 0.5%


Medication Information

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
Active Ingredient

Benzalkonium Chloride 0.13%

Uses

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

Helps protect against harmful bacteria.

Purpose

Topical Analgesic

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

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

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.

Description

Lidocaine HCL 0.5%

Section 51945-4

Questions

Call: 1-888-296-9067

Active Ingredient

Lidocaine HCL 0.5%

Storage Information

  • Store in cool dry area 15° to 25°C (59° to 79°F).
  • tamper evident sealed packets
  • do not use any opened or torn packets
Keep Out of Reach of Children

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


Structured Label Content

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
Active Ingredient (55106-9)

Benzalkonium Chloride 0.13%

Uses

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

Helps protect against harmful bacteria.

Purpose

Topical Analgesic

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

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

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.

Section 51945-4 (51945-4)

Questions

Call: 1-888-296-9067

Active Ingredient

Lidocaine HCL 0.5%

Storage Information

  • Store in cool dry area 15° to 25°C (59° to 79°F).
  • tamper evident sealed packets
  • do not use any opened or torn packets
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

All Sections (JSON)