SPL v1
SPL
SPL Set ID e76c059a-ac6f-46a9-a9b9-2a20ed532cd4
Route
TOPICAL
Published
Effective Date 2012-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg) Lidocaine (5 mg)
Inactive Ingredients
Aloe Vera Leaf Alcohol Methylparaben Mineral Oil Paraffin Propylparaben Water Petrolatum White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-01-27

Description

Drug Facts

Purpose

First Aid Antiseptic Topical analgesic


Medication Information

Purpose

First Aid Antiseptic

Topical analgesic

Description

Drug Facts

Uses
  • temporary relief of pain associated with minor cuts, scrapes, burns
  • helps protect against harmful bacteria
Section 42229-5

Drug Facts

Warnings

For external use only

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Do Not Use
  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor
Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Keep Out of Reach of Children.

If ingested contact a Poison Control Center right away.

Principal Display Panel – 0.9 Gram Packet

NDC 0924-5701-01

PhysiciansCARE

Burn Cream

0.9 g (1/32 oz.)

Acme United Corporation

Fairfield, CT 06824 800-835-2263

Principal Display Panel – Pac Kit Bag (0924 5701 02)

Unit 13-006 B

PAC-KIT FIRST AID

FIRST AID & BURN

CREAM PACKETS

ANSI Z308.1-2003R

Contents: 6 Single Use Packets

0.9 gr. (1/32 fl. oz.)

See reverse for Drug Facts.

Distributed by Acme United Corporation

Fairfield, CT 06824 · 800-835-2263

Principal Display Panel – Physicians Care Bag (0924 5701 03)

Item # 806031

PhysiciansCARE

FIRST AID & BURN

CREAM PACKETS

ANSI Z308.1-2003R

Contents: 6 Single Use Packets

0.9 gr. (1/32 fl. oz.)

See reverse for Drug Facts.

Distributed by Acme United Corporation

Fairfield, CT 06824 · 800-835-2263


Structured Label Content

Uses
  • temporary relief of pain associated with minor cuts, scrapes, burns
  • helps protect against harmful bacteria
Section 42229-5 (42229-5)

Drug Facts

Purpose

First Aid Antiseptic

Topical analgesic

Warnings

For external use only

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Do Not Use (Do not use)
  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor
Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Inactive Ingredients (Inactive ingredients)

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested contact a Poison Control Center right away.

Principal Display Panel – 0.9 Gram Packet (PRINCIPAL DISPLAY PANEL – 0.9 gram packet)

NDC 0924-5701-01

PhysiciansCARE

Burn Cream

0.9 g (1/32 oz.)

Acme United Corporation

Fairfield, CT 06824 800-835-2263

Principal Display Panel – Pac Kit Bag (0924 5701 02) (PRINCIPAL DISPLAY PANEL – Pac-Kit bag (0924-5701-02))

Unit 13-006 B

PAC-KIT FIRST AID

FIRST AID & BURN

CREAM PACKETS

ANSI Z308.1-2003R

Contents: 6 Single Use Packets

0.9 gr. (1/32 fl. oz.)

See reverse for Drug Facts.

Distributed by Acme United Corporation

Fairfield, CT 06824 · 800-835-2263

Principal Display Panel – Physicians Care Bag (0924 5701 03) (PRINCIPAL DISPLAY PANEL – Physicians Care bag (0924-5701-03))

Item # 806031

PhysiciansCARE

FIRST AID & BURN

CREAM PACKETS

ANSI Z308.1-2003R

Contents: 6 Single Use Packets

0.9 gr. (1/32 fl. oz.)

See reverse for Drug Facts.

Distributed by Acme United Corporation

Fairfield, CT 06824 · 800-835-2263


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)