MEDI-FIRST PLUS BURN CREAM- lidocaine cream
Unifirst First Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Medi-First Plus Burn Cream

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Purpose

Topical antiseptic

Topical analgesic

Uses

Firt aid to help prevent infection in minor cuts, scrapes and burns.

For temporary relief of pain and itching associated with:

sunburn
minor burns
insect bites
minor skin irritation
cuts
scrapes

Warnings

For external use only.

Do not use

in the eyes
over large areas of the body or on deep puncture wounds, animal bites or serious burns
in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

condition gets worse
condition clears up and recurs within a few days
condition persists for more than 7 days

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

Adults and children 12 years and over:

clean the affected area
apply a small amount of this product on the area 3 to 4 times daily
may be covered with a sterile bandage

Children under 12 years:

consult a doctor

Other information

store in a cool, dry area
59° to 79° F (15° to 25° C)
tamper evident sealed packets
do not use any open or torn packets

Inactive ingredients

buttylated hydroxytoluene, cetomacrogol, cetostearyl alcohol, dimethicone, glycerine, glyceryl monostearate, isopropyl myristate, methylcellulose, purified water, sodium EDTA, sodium methylparaben, sodium propylparaben

Questions or comments?

1-800-634-7680

Medi-First Plus Burn Cream Label

Medi-First Plus®

Burn Cream with Lidocaine

25 Units of 0.9gm Packets

Item #93973

Medi-First

MEDI-FIRST PLUS BURN CREAM
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-937
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETETH-20 (UNII: I835H2IHHX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-937-73	25 in 1 BOX	04/14/2016	08/02/2021
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2015	08/02/2021

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 10/2021

Document Id: ce27cc58-43d8-b027-e053-2995a90ae776

Set id: bfebe2e0-9383-4be2-b467-52ea74b5827c

Version: 9

Effective Time: 20211012

Unifirst First Aid Corporation