Fl-2044

Fl-2044
SPL v3
SPL
SPL Set ID 0f4ce2c2-f306-d95f-e063-6394a90ae7b3
Route
TOPICAL
Published
Effective Date 2024-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (50 mg)
Inactive Ingredients
Glycerin Propylparaben Sodium Ceteth-20 Methylparaben Sodium Butylated Hydroxytoluene Cetostearyl Alcohol Glyceryl Monostearate Water Edetate Sodium Isopropyl Myristate Methylcellulose (4000 Mpa.s) Dimethicone 350

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-26

Description

Lidocaine Hydrochloride 0.5%

Purpose

Topical Analgestic


Medication Information

Purpose

Topical Analgestic

Description

Lidocaine Hydrochloride 0.5%

Label

FL-2044

Use(s)

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

• Sunburn • Minor burns • Insect bites • Minor skin irritations • 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

Lidocaine Hydrochloride 0.5%

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

Stop Use and Aks A Doctor If

• The condition get 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 prfessional 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.


Structured Label Content

Label

FL-2044

Use(s)

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

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

Purpose

Topical Analgestic

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

Lidocaine Hydrochloride 0.5%

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

Stop Use and Aks A Doctor If (Stop use and aks a doctor if)

• The condition get worse • Condition clears up and recurs within a few days • Condition persists for more than 7 days

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

Ask a health care prfessional 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.


Advanced Ingredient Data


Raw Label Data

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