e76c059a-ac6f-46a9-a9b9-2a20ed532cd4

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

Purpose

First Aid Antiseptic Topical analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses
  • temporary relief of pain associated with minor cuts, scrapes, burns
  • helps protect against harmful bacteria
Purpose

First Aid Antiseptic

Topical analgesic

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Inactive Ingredients

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

Description

Drug Facts

Section 42229-5

Drug Facts

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%

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

Warnings

For external use only

Uses
  • temporary relief of pain associated with minor cuts, scrapes, burns
  • helps protect against harmful bacteria
Purpose

First Aid Antiseptic

Topical analgesic

Directions
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

Drug Facts

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%

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

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