FIRST AID AND BURN- benzalkonium chloride, lidocaine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

HART Health

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Topical Antiseptic Topical Anesthetic Uses: Temporary relief of pain and to help prevent infection in - minor cuts - scrapes - burns Do not use: - in or near the eyes - over large portions of the body - in large quantities particularly over raw surfaces or blistered areas - longer than 7 days unless directed by a doctor - more than 1 to 3 times daily Stop use and ask a doctor if - condition lasts for more than 7 days - condition worsens - symptoms clear up and occur again within a few days

Authorization status:

OTC monograph not final

Summary of Product characteristics

FIRST AID AND BURN- BENZALKONIUM CHLORIDE, LIDOCAINE CREAM
HART HEALTH
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FIRST AID & BURN CREAM
Active Ingredients (in each gram):
Benzalkonium Chloride 0.13%
Lidocaine HCl 0.5%
Purpose:
Topical Antiseptic
Topical Anesthetic
Uses: Temporary relief of pain and to help prevent infection in
minor cuts
scrapes
burns
Warnings: For external use only. See a doctor immediately for serious
burns
Do not use:
in or near the eyes
over large portions of the body
in large quantities particularly over raw surfaces or blistered areas
longer than 7 days unless directed by a doctor
more than 1 to 3 times daily
Ask a doctor before use if you have
serious burns
animal bites
deep or puncture wounds
Stop use and ask a doctor if
condition lasts for more than 7 days
condition worsens
symptoms clear up and occur again within a few days
Keep out of reach of children. If swallowed get medical help or
contact a Poison Control
Center right away. 1-800-222-1222
Directions: do not use more than directed
Adults and children 2 years of age and over:
clean the affected area
apply small amount of this product (an amount equal to the surface
area of the tip of
a finger) on the area 1 to 3 times daily
may be covered with a sterile bandage
Children under 2 years of age: ask a doctor
Inactive Ingredients: Aloe Vera, Cetyl Alcohol, Diazolidinyl Urea,
Edetate Disodium,
Glycerin, Clyceryl Monostearate, Methylparaben, Mineral Oil,
Polyethylene Glycol,
Propylene Glycol, Propylparaben, Purified Water, Stearic Acid,
Trolamine
FIRST AID AND BURN
benzalkonium chloride, lidocaine cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:50332-0037
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
.13 g
in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
.5 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UN