Green Guard Derma-caine

Green Guard Derma-caine
SPL v9
SPL
SPL Set ID 67629392-7e02-321a-e053-2991aa0a0f24
Route
TOPICAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Mineral Oil Propylparaben Aloe Vera Leaf Methylparaben Paraffin White Wax Alcohol Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-12

Description

Active ingredients Benzalkonium chloride 0.13% Lidocaine HCl 0.5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and 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
Dosage and 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
Description

Active ingredients Benzalkonium chloride 0.13% Lidocaine HCl 0.5%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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
Section 50570-1

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
Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments? 1-800-869-6970

Section 53414-9

If pregnant or breast feeding, ask a health care professional before use.

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Section 60561-8

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
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


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments? 1-800-869-6970

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health care professional before use.

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Section 60561-8 (60561-8)

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
Green Guard Derma Caine Burn Cream Label (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


Advanced Ingredient Data


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