DIABETIC FIRST AID GEL- benzalkonium chloride, lidocaine hydrochloride gel 
Lavior Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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 toll free 1-844-474-2552 or visit www.lavior.com

Diabetic First Aid Gel

DIABETIC FIRST AID GEL 
benzalkonium chloride, lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-390
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71521-390-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
2NDC:71521-390-1515 g in 1 TUBE; Type 0: Not a Combination Product03/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2021
Labeler - Lavior Inc. (080685327)

Revised: 3/2022
 
Lavior Inc.