ANTISEPTIC PAIN RELIEVING- benzalkonium chloride 0.10% benzocaine 20.00% spray 

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.



Drug Facts

Active ingredient                                     Purpose
Benzocaine USP  20%.......................................External analgesic

Benzalkonium Chloride   0.1%...........................First Aid Antiseptic


Temporarily relieves pain and itching due to: • sunburn • minor burns • minor cuts • scrapes • insect bites • minor skin irritations• first aid to help prevent infection in minor cuts, scrapes, bites and burns

For external use only.

Flammable: Do not use while smoking or near heat or flame Do not use in large quantities, particularly over raw surfaces or blistered areas
When using this product
• keep out of eyes
• do not apply over large areas of the body or in large quantites. in case of deep or puncture wounds, animal bites, or serious burns, concult a doctor
Stop use and ask doctor if
• condition gets worse • symptoms last more than 7 days
• symptoms clear up and occur again in a few days

•do not use longer than 1 week unless directed by doctor

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

Directions • 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: ask a doctor

Inactive Ingredients:
Alcohol Denat.
Diisopropyl Adipate
Propylene Glycol
Tocopheryl Acetate

image description

benzalkonium chloride 0.10% benzocaine 20.00% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7779
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 g  in 100 g
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) Benzocaine20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Diisopropyl Adipate (UNII: P7E6YFV72X)  
Propylene Glycol (UNII: 6DC9Q167V3)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-7779-0385 g in 1 CAN; Type 0: Not a Combination Product07/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2017
Labeler - Walgreens (008965063)
Registrant - Product Quest Mfg (927768135)
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(0363-7779) , label(0363-7779)

Revised: 4/2018
Document Id: f99f1d53-5eb8-4500-886d-7f3f6b127754
Set id: 3c418897-e559-4bff-a1e4-ee1ca76269f8
Version: 1
Effective Time: 20180427