Green Guard Derma-Caine Burn Cream

Drug Labeling and Warnings

Drug Details [pdf]

DERMA-CAINE- benzalkonium chloride, lidocaine hydrochloride 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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Green Guard Derma-Caine Burn Cream

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Purpose

Topical antiseptic

Topical analgesic

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

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 rae 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 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 opened or torn packets

Inactive ingredients

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

Questions or comments?

1-800-869-6970

Green Guard Derma-Caine Label

Green Guard®

Derma-Caine
burn cream

• For Minor Burns
• Soothing
• Promotes Healing
• Lessens Chance of Infection
  0.9 Gram

25 Single Dose Packets

Reorder #3106

DERMA-CAINE 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-399
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-399-71	20 in 1 BOX	01/31/2012	07/01/2019
1		1 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-399-12	10 in 1 BOX	01/31/2012	06/30/2017
2	NDC: 47682-399-99	1 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-399-73	25 in 1 BOX	06/27/2017	03/12/2018
3		1 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-399-35	144 in 1 BOX	01/31/2012	03/12/2018
4		1 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 not final	part348	01/31/2012	07/01/2019

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	manufacture(47682-399)

Revised: 3/2018

Document Id: 676453cd-8183-eee9-e053-2991aa0ac728

34390-5

Set id: f7c8eed6-4be9-4306-88a3-a3a45c678010

Version: 7

Effective Time: 20180314

 

Unifirst First Aid Corporation