Keepan A (Benzalkonium Chloride, Lidocaine Hydrochloride) Spray [Sato Pharmaceutical Co., Ltd.] -

KEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]
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NDC	49873-019-01
Set ID	a30679d5-5507-499d-9d9f-498095fd32ac
Category	HUMAN OTC DRUG LABEL
Packager	Sato Pharmaceutical Co., Ltd.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART333A

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/15/1981

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

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

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Medic

KEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]

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