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

Purpose

First Aid Antiseptic Topical Analgesic

Description

Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%


Medication Information

Warnings

For external use only.

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

First Aid Antiseptic

Topical Analgesic

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

Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%

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

Package Labeling:

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Keep Out of the Reach of Children.

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


Structured Label Content

Warnings

For external use only.

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

First Aid Antiseptic

Topical Analgesic

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

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

Package Labeling:

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

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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