MEDI-FIRST PLUS BURN WITH LIDOCAINE- benzalkonium chloride, lidocaine cream MEDI-FIRST BURN WITH LIDOCAINE- benzalkonium chloride, lidocaine cream

Medi-First Burn with Lidocaine by

Drug Labeling and Warnings

Medi-First Burn with Lidocaine by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Medique Products, Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

PURPOSE

Purpose

First aid antiseptic

Topical analgesic

INDICATIONS & USAGE

Uses

• for the temporary relief of pain associated with minor burns
• helps protect against harmful bacteria

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

• in the eyes
• in large quantities
• over raw or blistered areas, or on deep puncture wounds, aniaml bites, or serious burns
• for more than one week unless directed by a doctor

STOP USE

Stop use and ask a doctor if

• the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

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.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years and over: clean the affected area, apply a small amount not more than 3 to 4 times daily
• Children under 2 years: do not use, consult a doctor

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments? 800-634-7680

PRINCIPAL DISPLAY PANEL

Medi-First®

Burn Cream with Lidocaine

Benzalkonium Chloride 0.13% / Topical Antiseptic

Lidocaine HCl 0,5% / Topical Analgesic

Antiseptic and pain relieving cream for minor burns

Item #26073

NetWt. 0.9 g (1/32 oz) Packets / 25 per box

Made in China

PRINCIPAL DISPLAY PANEL

Medi-First® Plus

Burn Cream with Lidocaine

Benzalkonium Chloride 0.13% / Lidocaine HCl 0.5%

Topical Antiseptic / Topical Analgesic

Net Wt. 0.9 g (1/32 oz) Packets / 25 per box

Item #93973

Made in China

INGREDIENTS AND APPEARANCE

MEDI-FIRST PLUS BURN WITH LIDOCAINE 
benzalkonium chloride, lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-985
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MINERAL OIL (UNII: T5L8T28FGP)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-985-73	25 in 1 BOX	04/01/2023
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	04/01/2023

MEDI-FIRST BURN WITH LIDOCAINE 
benzalkonium chloride, lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-984
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MINERAL OIL (UNII: T5L8T28FGP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-984-73	25 in 1 BOX	04/01/2023
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	04/01/2023

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(47682-984, 47682-985)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	pack(47682-984, 47682-985)