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.

Active Ingredient

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

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 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

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

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
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 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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