Green Guard Derma-Caine Burn (Benzalkonium Chloride, Lidocaine Hcl) Cream [Unifirst First Aid Corporation] -

GREEN GUARD DERMA-CAINE BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HCL) CREAM [UNIFIRST FIRST AID CORPORATION]
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NDC	47682-319-35, 47682-319-73, 47682-319-99
Set ID	67629392-7e02-321a-e053-2991aa0a0f24
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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Drug Facts
ACTIVE INGREDIENT

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%
PURPOSE

Purpose

Topical analgesic
INDICATIONS & USAGE
Uses

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

For the temporary relief of pain or itching associated with:
- sunburn
- minor burns
- insect bites
- minor skin irritation
- cuts
- scrapes
WARNINGS
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
- 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.
DOSAGE & ADMINISTRATION
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 SAFETY INFORMATION
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 INGREDIENT

Inactive ingredients

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white petrolatum, white wax
QUESTIONS

Questions or comments? 1-800-869-6970
Green Guard Derma-Caine Burn Cream Label

Green Guard

Derma-Caine burn cream

Antiseptic and pain relieving cream for monor cuts, scrapes and burns

Benzalkonium Chloride 0.13%/Topical Antiseptic

Lidocaine HCl 0.5%/Topical Analgesic

0.9 Gram 25 Single Dose Packets

Reorder #3106

Distributed by Green Guard®, Str. Louis, Missouri 63045

INGREDIENTS AND APPEARANCE

GREEN GUARD DERMA-CAINE BURN
benzalkonium chloride, lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-319
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)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
WHITE WAX (UNII: 7G1J5DA97F)
ALCOHOL (UNII: 3K9958V90M)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-319-73	25 in 1 BOX	03/12/2018
1	NDC:47682-319-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-319-35	144 in 1 BAG	03/12/2018
2		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	03/12/2018

Labeler - Unifirst First Aid Corporation (832947092)

Name	Address	ID/FEI	Business Operations
Establishment
Prestige Packaging		080667761	repack(47682-319)

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Medic

GREEN GUARD DERMA-CAINE BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HCL) CREAM [UNIFIRST FIRST AID CORPORATION]

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