Keepan A

Keepan A
SPL v4
SPL
SPL Set ID a30679d5-5507-499d-9d9f-498095fd32ac
Route
TOPICAL
Published
Effective Date 2019-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Alcohol Hydrochloric Acid Water Sodium Chloride Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1981-07-15

Description

Active ingredients Benzalkonium chloride 0.1% Lidocaine hydrochloride 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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



Dosage and 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.

Description

Active ingredients Benzalkonium chloride 0.1% Lidocaine hydrochloride 1%

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product

■ avoid contact with the eyes

Section 50569-3

Ask a doctor before use if you have

■ deep or puncture wounds ■ animal bites ■ serious burns



Section 50570-1

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



Section 51727-6

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

Section 51945-4

Section 55105-1

Purpose

Benzalkonium chloride    First aid antiseptic

Lidocaine hydrochloride    External analgesic

Section 55106-9

Active ingredients

Benzalkonium chloride 0.1%

Lidocaine hydrochloride 1%


Structured Label Content

Indications and Usage (34067-9)

Uses  First aid for minor cuts, scrapes and burns:

■ to help reduce the risk of infection

■ for the temporary relief of pain and itching



Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

■ avoid contact with the eyes

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ deep or puncture wounds ■ animal bites ■ serious burns



Section 50570-1 (50570-1)

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



Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Benzalkonium chloride    First aid antiseptic

Lidocaine hydrochloride    External analgesic

Section 55106-9 (55106-9)

Active ingredients

Benzalkonium chloride 0.1%

Lidocaine hydrochloride 1%


Advanced Ingredient Data


Raw Label Data

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