61010-5300, Cut And Scrape Antiseptic

61010-5300, Cut And Scrape Antiseptic
SPL v4
SPL
SPL Set ID 458e65f2-826d-4550-8c7d-17add2d7ba9a
Route
TOPICAL
Published
Effective Date 2012-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg) Benzocaine (50 mg)
Inactive Ingredients
Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-02-15

Description

Drug Facts

Purpose

First Aid Antiseptic Topical Pain Relief


Medication Information

Purpose

First Aid Antiseptic

Topical Pain Relief

Description

Drug Facts

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Section 42229-5

Drug Facts

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 doctor ifcondition persists or gets worse

Warnings

For external use only. Flammable keep away from fire or flame.

Directions
  • clean affected and spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 ask a doctor.
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 Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Inactive Ingredients

isopropyl alcohol, purified water

Principal Display Panel – Bottle Label

NDC 61010-5300-0

Safetec

Cut & Scrape

Antiseptic Spray

For Temporary Pain

Relief and to Help

Prevent Infection in

Minor Cuts, Scrapes

and Abrasions.

2 fl. oz. (59.1ml)

Reorder no. 53000


Structured Label Content

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Section 42229-5 (42229-5)

Drug Facts

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 doctor ifcondition persists or gets worse

Purpose

First Aid Antiseptic

Topical Pain Relief

Warnings

For external use only. Flammable keep away from fire or flame.

Directions
  • clean affected and spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 ask a doctor.
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 Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Inactive Ingredients (Inactive ingredients)

isopropyl alcohol, purified water

Principal Display Panel – Bottle Label (PRINCIPAL DISPLAY PANEL – bottle label)

NDC 61010-5300-0

Safetec

Cut & Scrape

Antiseptic Spray

For Temporary Pain

Relief and to Help

Prevent Infection in

Minor Cuts, Scrapes

and Abrasions.

2 fl. oz. (59.1ml)

Reorder no. 53000


Advanced Ingredient Data


Raw Label Data

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