FDA Label for Keepan A

View Indications, Usage & Precautions

Keepan A Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients
Benzalkonium chloride 0.1%
Lidocaine hydrochloride 1%


Otc - 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


Otc - Do Not Use



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


Otc - Ask Doctor



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


Otc - When Using



When using this product
■ avoid contact with the eyes


Otc - Stop Use



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


Otc - 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:
■ 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


Package Label.Principal Display Panel



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