SPL v5
SPL
SPL Set ID 75bfd7f9-22e6-4ed9-ad96-961b0355d73e
Route
TOPICAL
Published
Effective Date 2016-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 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 External analgesic


Medication Information

Purpose

First Aid Antiseptic

External analgesic

Description

Drug Facts

Uses

first aid to help prevent infection and for the temporary relief of itching associated with

  • minor cuts
  • scrapes
  • 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 50567-7

When using this product avoid contact with eyes

Section 50569-3

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
  • clean the affected area
  • apply a small amount of this product to the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 years of age: consult a doctor
Do Not Use
  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas
Other Information
  • store at room temperature
  • do not use if packet is opened or torn
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

Questions? 1 800 835 2263

REORDER

www.PhysiciansCareFirstAid.com

1 800 835 2263

Stop Use and Ask A Doctor If
  • condition worsens or persists for more than 7 days
  • clears up and occurs again within a few days
Principal Display Panel Packet Label

FIRST AID ONLY ®

Burn Cream

NET WT 1/32 oz (0.9g)

© 2015 Acme United Corporation.

Faifield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

NDC 0924-5701-01


Structured Label Content

Uses

first aid to help prevent infection and for the temporary relief of itching associated with

  • minor cuts
  • scrapes
  • 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 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50569-3 (50569-3)

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Purpose

First Aid Antiseptic

External analgesic

Warnings

For external use only

Directions
  • adults and children 2 years of age and older:
  • clean the affected area
  • apply a small amount of this product to the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 years of age: consult a doctor
Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas
Other Information (Other information)
  • store at room temperature
  • do not use if packet is opened or torn
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

Questions? 1 800 835 2263 (Questions? 1-800-835-2263)

REORDER

www.PhysiciansCareFirstAid.com

1 800 835 2263

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or persists for more than 7 days
  • clears up and occurs again within a few days
Principal Display Panel Packet Label (Principal Display Panel - Packet Label)

FIRST AID ONLY ®

Burn Cream

NET WT 1/32 oz (0.9g)

© 2015 Acme United Corporation.

Faifield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

NDC 0924-5701-01


Advanced Ingredient Data


Raw Label Data

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