Burn Gel

Burn Gel
SPL v3
SPL
SPL Set ID c20f9d77-2572-4050-8b8c-8337ca67124e
Route
TOPICAL
Published
Effective Date 2016-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Diazolidinyl Urea Water Menthol .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-02-14

Description

Drug Facts

Purpose

Topical pain relief


Medication Information

Purpose

Topical pain relief

Description

Drug Facts

Uses

Temporary pain relief of minor burns. For professional use only.

Section 42229-5

Drug Facts

Directions

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use, consult a doctor

Do Not Use
  • In large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water
Other Information
  • store at room temperature (do not freeze)
  • do not use any opened or torn packs
Active Ingredients

Lidocaine HCl 2%

Inactive Ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, Vitamin E acetate

Stop Use and Ask Doctor If
  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel Pouch Label

FIRST AID ONLY ®

Burn Gel

For Temporary

Pain Relief of

Minor Burns

NET WT 3.5g

Distributed by

© 2016 Acme United Corporation.

Fairfield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

For External Use Only. Keep Out of Reach of Children.

If ingested, get medical help or contact a Poison Control Center directly


Structured Label Content

Uses

Temporary pain relief of minor burns. For professional use only.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Topical pain relief

Directions

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use, consult a doctor

Do Not Use (Do not use)
  • In large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water
Other Information (Other information)
  • store at room temperature (do not freeze)
  • do not use any opened or torn packs
Active Ingredients (Active ingredients)

Lidocaine HCl 2%

Inactive Ingredients (Inactive ingredients)

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, Vitamin E acetate

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel Pouch Label (Principal Display Panel - Pouch Label)

FIRST AID ONLY ®

Burn Gel

For Temporary

Pain Relief of

Minor Burns

NET WT 3.5g

Distributed by

© 2016 Acme United Corporation.

Fairfield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

For External Use Only. Keep Out of Reach of Children. (For external use only. Keep out of reach of children.)

If ingested, get medical help or contact a Poison Control Center directly


Advanced Ingredient Data


Raw Label Data

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