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.

Active Ingredient

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

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 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

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

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
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 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


Raw Label Data

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