SPL v1
SPL
SPL Set ID d11f5df7-b239-a407-e053-2995a90a728b
Route
TOPICAL
Published
Effective Date 2021-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg) Pramoxine (10 mg)
Inactive Ingredients
Water Edetate Disodium Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-11-19

Description

BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE;


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

• cuts

• scrapes

• burns

Dosage and Administration

• Adults and children 2 years of age and older:

• Clean the affected area

• Spray a small amount of this product on the area 1 to 3 times daily.

• May be covered with a sterile bandage

• If bandaged, let dry first

• Children under 2 years of age: consult a doctor

Description

BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE;

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

• condition or symptoms get worse or last more than one week

• symptoms clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Centre right away.

Section 50569-3

• deep or puncture wounds

• animal bites

• serious burns

Section 50570-1

• in the eyes

• over large areas of the body

Section 51727-6

Water, Propylene Glycol, Edetate Disodium

Section 51945-4

NDC: 82199-610-26 7.7ml in 1 Vial

Section 55105-1

First aid antibiotic

Topical analgesic

Section 55106-9

BENZALKONIUM CHLORIDE;

PRAMOXINE HYDROCHLORIDE;

Section 60561-8

Store at Room Temperature


Structured Label Content

Indications and Usage (34067-9)

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

• cuts

• scrapes

• burns

Dosage and Administration (34068-7)

• Adults and children 2 years of age and older:

• Clean the affected area

• Spray a small amount of this product on the area 1 to 3 times daily.

• May be covered with a sterile bandage

• If bandaged, let dry first

• Children under 2 years of age: consult a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

• condition or symptoms get worse or last more than one week

• symptoms clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Centre right away.

Section 50569-3 (50569-3)

• deep or puncture wounds

• animal bites

• serious burns

Section 50570-1 (50570-1)

• in the eyes

• over large areas of the body

Section 51727-6 (51727-6)

Water, Propylene Glycol, Edetate Disodium

Section 51945-4 (51945-4)

NDC: 82199-610-26 7.7ml in 1 Vial

Section 55105-1 (55105-1)

First aid antibiotic

Topical analgesic

Section 55106-9 (55106-9)

BENZALKONIUM CHLORIDE;

PRAMOXINE HYDROCHLORIDE;

Section 60561-8 (60561-8)

Store at Room Temperature


Advanced Ingredient Data


Raw Label Data

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