Genuine First Aid Pain Relieving Cream

Genuine First Aid Pain Relieving Cream
SPL v3
SPL
SPL Set ID 48867a79-4d21-4ba1-9cf9-7839352a4b7e
Route
TOPICAL
Published
Effective Date 2024-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Aloe Vera Leaf Cetostearyl Alcohol Edetate Disodium Anhydrous Ethylhexylglycerin Glycerin Glyceryl Stearate/peg-100 Stearate Maltodextrin Mineral Oil Phenoxyethanol Propylene Glycol Water Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01

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 cuts, scrapes, and burns.
  • Helps pretect against harmful bacteria.
Warnings

For external use only.

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
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

Drug Facts

Other Information
  • store in a cool dry area 15° to 25° C (59° to 79°F)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Package Labeling:

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

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

Keep Out of the Reach of Children.

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


Structured Label Content

Uses
  • Temporary relief of pain associated with minor cuts, scrapes, and burns.
  • Helps pretect against harmful bacteria.
Purpose

First Aid Antiseptic

Topical Analgesic

Warnings

For external use only.

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Do Not Use (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

Drug Facts

Other Information (Other information)
  • store in a cool dry area 15° to 25° C (59° to 79°F)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Package Labeling:

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

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

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 directly.


Advanced Ingredient Data


Raw Label Data

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