KEEPAN A- benzalkonium chloride, lidocaine hydrochloride spray

KEEPAN A by

Drug Labeling and Warnings

KEEPAN A by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Benzalkonium chloride 0.1%
Lidocaine hydrochloride 1%

PURPOSE

Purpose
Benzalkonium chloride    First aid antiseptic
Lidocaine hydrochloride    External analgesic

INDICATIONS & USAGE

Uses  First aid for minor cuts, scrapes and burns:
■ to help reduce the risk of infection
■ for the temporary relief of pain and itching

WARNINGS

Warnings
For external use only

Do not use
■ in the eyes    ■ in large quantities
■ over large areas of the body    ■ over raw surfaces or blistered areas
■ longer than 1 week unless directed by a doctor

Ask a doctor before use if you have
■ deep or puncture wounds ■ animal bites ■ serious burns

When using this product
■ avoid contact with the eyes

Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days, or clear up and occur again within a few days
■ irritation, redness, swelling or pain persists or increases or a rash or infection develops

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:
■ clean the affected area
■ spray a small amount directly on the affected area or apply with clean gauze or cotton saturated with KEEPAN A 1 to 3 times daily
■ may be covered with a sterile bandage
■ if bandaged, let dry first
Children under 2 years of age: Do not use, consult a doctor.

INACTIVE INGREDIENT

Inactive ingredients  alcohol, fragrance, hydrochloric acid, purified water, sodium chloride, sodium citrate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KEEPAN A 
benzalkonium chloride, lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-019
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 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-019-01	1 in 1 CARTON	07/15/1981
1		60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/1981

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-019) , label(49873-019) , pack(49873-019)