FOOT WORKS MAXIMUM CRACKED HEEL- benzalkonium chloride, lidocaine cream

FOOT WORKS MAXIMUM CRACKED HEEL by

Drug Labeling and Warnings

FOOT WORKS MAXIMUM CRACKED HEEL by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine 4%

PURPOSE

Purpose

First aid antiseptic

External analgesic

USES

Uses

• first aid to help reduce the risk of skin infection in minor cuts, scrapes and burns
• first aid for the temporary reflief of pain in minor cuts, scrapes and burns

WARNINGS

Warnings

For external use only

• do not use in the eyes or apply over large areas of the body
• do not use in large quantities, particularly over raw surfaces or blistered areas
• consult a doctor in the case of deep or puncture wounds, animal bites, or serious burns
• if condition worsens, of if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use longer than 1 week unless directed by a doctor

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Directions

Adults and children 2 years of age and older

• clean the affected area
• apply a small amount of this product on the affected are 1 to 3 times daily
• may be covered with a sterile bandage

Children under 2 years of age

• consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Isopropyl Palmitate, Glyceryl Stearate, Cetyl Alcohol, Stearyl Alcohol, Glycerin, Lanolin Wax, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 80, Benzyl Alcohol, Carbomer, Methylparaben, Disodium EDTA, Allantoin, Alcohol, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOOT WORKS MAXIMUM CRACKED HEEL 
benzalkonium chloride, lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALLANTOIN (UNII: 344S277G0Z)
CITRIC ACID (UNII: 2968PHW8QP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALCOHOL (UNII: 3K9958V90M)
VITIS VINIFERA (GRAPE) SEED OIL (UNII: 930MLC8XGG)
GLYCERIN (UNII: PDC6A3C0OX)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-195-00	750 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/01/2024

Labeler - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-195)