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

Antiseptic Medicated by

Drug Labeling and Warnings

Antiseptic Medicated by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

INDICATIONS & USAGE

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

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC MEDICATED  CVS
benzalkonium chloride 0.10% benzocaine 20.00% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-854
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.1 g  in 100 g
Benzocaine (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	Benzocaine	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
Diisopropyl Adipate (UNII: P7E6YFV72X)
Propylene Glycol (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-854-03	69 g in 1 JAR; Type 0: Not a Combination Product	03/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/15/2017

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(69842-854) , label(69842-854)