2044 First Aid Burn Cream

2044 First Aid Burn Cream
SPL v3
SPL
SPL Set ID f70a442e-7ba7-4860-e053-6394a90ac2bd
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.5 g)
Inactive Ingredients
Butylated Hydroxytoluene Cetostearyl Alcohol Glycerin Glyceryl Monostearate Isopropyl Myristate Methylparaben Sodium Propylparaben Sodium Methylcellulose (4000 Cps) Water Edetate Sodium Ceteth-20 Dimethicone 350

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-10

Description

Benzalkonium Chloride 0.13%

Purpose

Benzalkonium Chloride Topical Antiseptic Lidocaine Hydrochloride Topical Analgesic


Medication Information

Purpose

Benzalkonium Chloride Topical Antiseptic

Lidocaine Hydrochloride Topical Analgesic

Description

Benzalkonium Chloride 0.13%

Label

First Aid Burn Cream

Use(s)

• For the temporary relief of pain and itching associated with:

• Sunburn • Minor burns • Insect bites • Minor skin irritation • Cuts • Scrapes

Warnings

For External Use Only

Directions

Adults and children 2 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 2 years:

• Consult a doctor

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

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

• Store in a cool, dry area 15º-25ºC (59º-77ºF)

• Tamper evident sealed packets

• Do not use any opened or torn packets

Inactive Ingredients

Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

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 (1-800-222-1222) right away.

Stop Use and Ask A Dioctor If

• The condition gets worse

• Condition clears up and recurs within a few days

• Condition persists for more than 7 days


Structured Label Content

Label

First Aid Burn Cream

Use(s)

• For the temporary relief of pain and itching associated with:

• Sunburn • Minor burns • Insect bites • Minor skin irritation • Cuts • Scrapes

Purpose

Benzalkonium Chloride Topical Antiseptic

Lidocaine Hydrochloride Topical Analgesic

Warnings

For External Use Only

Directions

Adults and children 2 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 2 years:

• Consult a doctor

Do Not Use (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

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

• Store in a cool, dry area 15º-25ºC (59º-77ºF)

• Tamper evident sealed packets

• Do not use any opened or torn packets

Inactive Ingredients

Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health care professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Dioctor If (Stop use and ask a dioctor if)

• The condition gets worse

• Condition clears up and recurs within a few days

• Condition persists for more than 7 days


Advanced Ingredient Data


Raw Label Data

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