Antibacterial Lidocaine Wound Gel

Antibacterial Lidocaine Wound Gel
SPL v3
SPL
SPL Set ID ef1a6100-7f78-1fdb-e053-2a95a90abf20
Route
TOPICAL
Published
Effective Date 2019-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (2 g)
Inactive Ingredients
Caprylyl Glycol Edetate Disodium Hydroxyethyl Cellulose, Unspecified Water Glycerin Phenoxyethanol Polysorbate 20 Chlorphenesin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-28

Description

Benzalkonium Chloride 0.13% Lidocaine Hydrochloride 2.00%

Purpose

first aid antiseptic external analgesic


Medication Information

Purpose

first aid antiseptic

external analgesic

Description

Benzalkonium Chloride 0.13% Lidocaine Hydrochloride 2.00%

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

For the temporary relief of pain associated with minor burns

Warnings

For external use only

Directions

clean the affected area

adults and children 2 years of age and older:

apply to affected area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

may be covered with a sterile bandage

if bandaged, let dry first

Do Not Use

in the eyes

over large areas of the body, particularly over raw surfaces or blistered areas

longer than a week unless directed by a doctor

Other Information

Store at room temperature

Inactive Ingredients

caprylyl glycol, chlorphenesin, edetate disodium, glycerin, hydroxyethyl cellulose, phenoxyethanol, polysorbate 20, purified water

Principal Display Panel

Stop Use and Ask A Doctor If

the condition persists more than 7 days or gets worse

Condition clears up and occurs again within a few days

Keep Out of Reach of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Active Ingredients (in Each Gram)

Benzalkonium Chloride 0.13%

Lidocaine Hydrochloride 2.00%

Ask A Doctor Before Use If You Have

deep or puncture wounds

animal bites

serious burns


Structured Label Content

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

For the temporary relief of pain associated with minor burns

Purpose

first aid antiseptic

external analgesic

Warnings

For external use only

Directions

clean the affected area

adults and children 2 years of age and older:

apply to affected area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

may be covered with a sterile bandage

if bandaged, let dry first

Do Not Use (Do not use)

in the eyes

over large areas of the body, particularly over raw surfaces or blistered areas

longer than a week unless directed by a doctor

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

caprylyl glycol, chlorphenesin, edetate disodium, glycerin, hydroxyethyl cellulose, phenoxyethanol, polysorbate 20, purified water

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

the condition persists more than 7 days or gets worse

Condition clears up and occurs again within a few days

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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Benzalkonium Chloride 0.13%

Lidocaine Hydrochloride 2.00%

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds

animal bites

serious burns


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)