Burn With Lidocaine (Benzalkonium Chloride, Lidocaine Hydrochloride) Cream [Unifirst First Aid Corporation] -

BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]
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NDC	47682-260-12, 47682-260-73, 47682-260-99
Set ID	81363387-d4b1-4c3f-b67f-5017361c0fcd
Category	HUMAN OTC DRUG LABEL
Packager	Unifirst First Aid Corporation
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%
Purpose

Topical antiseptic

Topicall analgesic
Uses
First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:
- sunburn
- insect bites
- cuts
- minor skin irritations
- scrapes
- minor burns
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 doctor if
- the 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 care 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 2 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
Children under 2 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 opened or torn packets
Inactive ingredients

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax
Questions or comments?

1-800-634-7680
MF Burn Cream with Lidocaine Label

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 cuts, scrapes and burns

Product # 26073

0.9 gram Packets - 25 per box

INGREDIENTS AND APPEARANCE

BURN WITH LIDOCAINE
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-260
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-260-73	25 in 1 BOX	01/24/2012
1	NDC:47682-260-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-260-12	10 in 1 BOX	07/03/2017
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC:47682-260-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product	01/24/2012