KEEPAN A

Dosage form: spray
Ingredients: BENZALKONIUM CHLORIDE 0.1g in 100mL, LIDOCAINE HYDROCHLORIDE 1g in 100mL
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-019

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 ingredients
Benzalkonium chloride 0.1%
Lidocaine hydrochloride 1%

Purpose
Benzalkonium chloride    First aid antiseptic
Lidocaine hydrochloride    External analgesic

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
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.

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


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KEEPAN A 
benzalkonium chloride, lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
HYDROCHLORIC ACID 
WATER 
SODIUM CHLORIDE 
TRISODIUM CITRATE DIHYDRATE 
Packaging
#Item CodePackage Description
1NDC:49873-019-011 BOTTLE, SPRAY (BOTTLE) in 1 CARTON
160 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/1981
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 03/2012
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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