Otc - Active Ingredient
Active ingredients
Benzalkonium chloride 0.1%
Lidocaine hydrochloride 1%
Keepan A Spray
FDA Label NDC 49873-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Keepan A (NDC 49873-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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