78495-122

78495-122
SPL v2
SPL
SPL Set ID b6efaca5-49d0-b000-e053-2995a90ab9aa
Route
topical
Published
Effective Date 2020-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-19

Purpose

First aid antiseptic

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only.

Flammable, keep away from fire or flame.

Uses

First aid to help prevent infection in minor cuts, scrapes & burns

Purpose

First aid antiseptic

Directions
  • clean affected area & spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • not to be used on children under 12 years of age

Inactive Ingredients

ethyl alcohol, purified water

Description

Benzalkonium Chloride 0.13%

Section 42229-5

Treats minor cuts, scrapes and abrasions

Helps prevent infection

Store at 68°-77°F (20°-25°C)

Section 51945-4

Do Not Use
  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor
Active Ingredient

Benzalkonium Chloride 0.13%

Questions Or Comments?

1-800-634-7680

Stop Use and Ask A Doctor

if condition persists or gets worse

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only.

Flammable, keep away from fire or flame.

Uses

First aid to help prevent infection in minor cuts, scrapes & burns

Purpose

First aid antiseptic

Directions
  • clean affected area & spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • not to be used on children under 12 years of age

Inactive Ingredients (Inactive ingredients)

ethyl alcohol, purified water

Section 42229-5 (42229-5)

Treats minor cuts, scrapes and abrasions

Helps prevent infection

Store at 68°-77°F (20°-25°C)

Section 51945-4 (51945-4)

Do Not Use (Do not use)
  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor
Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Questions Or Comments? (Questions or comments?)

1-800-634-7680

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if condition persists or gets worse

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.


Advanced Ingredient Data


Raw Label Data

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