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

GG Derma- Caine Safetec

DERMA-CAINE 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-399
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-399-7120 in 1 BOX01/31/201207/01/2019
11 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:47682-399-1210 in 1 BOX01/31/201206/30/2017
2NDC:47682-399-991 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:47682-399-7325 in 1 BOX06/27/201703/12/2018
31 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:47682-399-35144 in 1 BOX01/31/201203/12/2018
41 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/201207/01/2019
Labeler - Unifirst First Aid Corporation (832947092)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(47682-399)

Revised: 3/2018
Document Id: 676453cd-8183-eee9-e053-2991aa0ac728
Set id: f7c8eed6-4be9-4306-88a3-a3a45c678010
Version: 7
Effective Time: 20180314
 
Unifirst First Aid Corporation