Medi-first Burn Cream With Lidocaine

Medi-first Burn Cream With Lidocaine
SPL v6
SPL
SPL Set ID bd46efc8-0b36-0931-e053-2a95a90adb6f
Route
TOPICAL
Published
Effective Date 2021-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Trolamine Glycerin Water Edetate Disodium Methylparaben Glyceryl Stearate Se Propylparaben Cetyl Alcohol Diazolidinyl Urea Propylene Glycol Glyceryl Stearate/peg-100 Stearate Stearic Acid Mineral Oil Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-06-01 Until 2028-04-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

first aid to help prevent infection and for the temporary relief of pain and itching associated with

  • minor cuts
  • scrapes
  • burns
Dosage and Administration

Directions

  • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage

  • children under 2 years of age: consult a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Section 50567-7

When using this product avoid contact with the eyes

Section 50569-3

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

Section 50570-1

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas
Section 51727-6

Inactive ingredients

aloe barbadensis leaf juice, cetyl alcohol, diazolidinyl urea, disodiun EDTA,, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG 100, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Section 51945-4

Medi-First®

Burn Cream with Lidocaine

Benzalkonium Chloride 0.13% / First Aid Antiseptic

Lidocaine HCl 0.5% / External Analgesic

Product # 20669

10 Units Net Wt 0.9 g (1/32 oz)

Section 53413-1

Questions or comments? 1-800-634-7680

Section 55105-1

Purposes

First aid antiseptic

External analgesic

Section 55106-9

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Section 60561-8

Other information

  • store at room temperature
  • tamper evident. Do not use if packet is opened or torn
  • you may report a serious adverse reaction to this product to 800-634-7680


Structured Label Content

Indications and Usage (34067-9)

Uses

first aid to help prevent infection and for the temporary relief of pain and itching associated with

  • minor cuts
  • scrapes
  • burns
Dosage and Administration (34068-7)

Directions

  • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage

  • children under 2 years of age: consult a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50569-3 (50569-3)

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

Section 50570-1 (50570-1)

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas
Section 51727-6 (51727-6)

Inactive ingredients

aloe barbadensis leaf juice, cetyl alcohol, diazolidinyl urea, disodiun EDTA,, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG 100, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Section 51945-4 (51945-4)

Medi-First®

Burn Cream with Lidocaine

Benzalkonium Chloride 0.13% / First Aid Antiseptic

Lidocaine HCl 0.5% / External Analgesic

Product # 20669

10 Units Net Wt 0.9 g (1/32 oz)

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 55105-1 (55105-1)

Purposes

First aid antiseptic

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Section 60561-8 (60561-8)

Other information

  • store at room temperature
  • tamper evident. Do not use if packet is opened or torn
  • you may report a serious adverse reaction to this product to 800-634-7680


Advanced Ingredient Data


Raw Label Data

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