Unishield First Aid & Burn Cream

Unishield First Aid & Burn Cream
SPL v1
SPL
SPL Set ID f86f7446-b741-9f40-e053-6394a90a4422
Route
TOPICAL
Published
Effective Date 2023-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5 mg)
Inactive Ingredients
Glyceryl Monostearate Mineral Oil Maltodextrin Peg-100 Stearate Stearic Acid Ethylhexylglycerin Phenoxyethanol Water Glycerin Edetate Disodium Anhydrous Propylene Glycol Trolamine Aloe Vera Leaf Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-04-03

Description

Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%

Purpose

First aid antiseptic Topical analgesic


Medication Information

Purpose

First aid antiseptic

Topical analgesic

Description

Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%

Uses
  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Section 51945-4

Warnings

For external use only.

Directions
  • clean affected area
  • apply a small amount not more than 3-4 times daily
  • children under 2 years: do not use,consult a doctor
Do Not Use
  • in eyes
  • in large quantities
  • over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor
Active Ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Other Information
  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA,ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol,purified water, PEG-100 Stearate, phenoxyethanol, stearic acid, triethanolamine

Questions Or Comments?

1-800-480-5855

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria
Section 51945-4 (51945-4)

Purpose

First aid antiseptic

Topical analgesic

Warnings

For external use only.

Directions
  • clean affected area
  • apply a small amount not more than 3-4 times daily
  • children under 2 years: do not use,consult a doctor
Do Not Use (Do not use)
  • in eyes
  • in large quantities
  • over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor
Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Other Information
  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA,ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol,purified water, PEG-100 Stearate, phenoxyethanol, stearic acid, triethanolamine

Questions Or Comments? (Questions or comments?)

1-800-480-5855

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

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


Advanced Ingredient Data


Raw Label Data

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