DIABETIC FIRST AID GEL- benzalkonium chloride, lidocaine hydrochloride gel

Diabetic First Aid Gel by

Drug Labeling and Warnings

Diabetic First Aid Gel by is a Otc medication manufactured, distributed, or labeled by Lavior Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.13% .................Topical Antiseptic
Lidocaine Hydrochloride 0.5% .................Topical Analgesic

Purpose

Topical Antiseptic
Topical Analgesic

Uses

First aid to help prevent infection in minor:

■cuts ■scrapes ■burns

Temporarily relieves pain and itching associated with:

■minor burns ■cuts ■scrapes ■insect bites ■minor skin irritations

Warnings

For external use only

Do not use

• in the eyes
• over large areas of the body
• in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• condition or symptoms get worse or last more than 1 week
• 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.

Directions

Adults and children 12 years of age and older:

• clean the affected area
• apply a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first

Children under 12 years of age: consult a doctor

Other information

Store at room temperature

Inactive Ingredients

Water, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Aloe Barbadensis Leaf Juice, Xanthan Gum, Phenoxyethanol, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Gluconolactone, Polyvinyl Alcohol, Alcohol, Citric Acid, Sodium Benzoate, Potassium Sorbate

Questions?

Call (305) 627-3680 or visit www.lavior.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIABETIC FIRST AID GEL 
benzalkonium chloride, lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71521-390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71521-390-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/31/2021
2	NDC: 71521-390-15	15 g in 1 TUBE; Type 0: Not a Combination Product	03/17/2022
3	NDC: 71521-390-30	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/31/2021

Labeler - Lavior Pharma Inc. (080685327)