ANTISEPTIC MEDICATED CVS- benzalkonium chloride 0.10% benzocaine 20.00% liquid 
CVS

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.

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Drug Facts

Active ingredient                                     Purpose
Benzocaine.............................................External analgesic

Benzalkonium Chloride...........................First Aid Antiseptic

Uses

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

Warnings
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

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ANTISEPTIC MEDICATED  CVS
benzalkonium chloride 0.10% benzocaine 20.00% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-854
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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-854-0369 g in 1 JAR; Type 0: Not a Combination Product03/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/15/2017
Labeler - CVS (062312574)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(69842-854) , label(69842-854)

Revised: 4/2017
Document Id: 22c7ee82-2641-48d6-868c-a605b5a43965
Set id: 495a1c90-187e-461d-b7b4-561913f4b1ca
Version: 1
Effective Time: 20170428
 
CVS