SPL v2
SPL
SPL Set ID 3dfb4c70-1bbf-4c77-9d8d-e135dbea15d2
Route
TOPICAL
Published
Effective Date 2012-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (200 mL)
Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Diazolidinyl Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-02-16

Description

Drug Facts

Purpose

Topical pain relief


Medication Information

Purpose

Topical pain relief

Description

Drug Facts

Uses

Temporary pain relief for minor burns

Section 42229-5

Drug Facts

Section 50566-9

Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and returns

Warnings

For external use only

Directions
  • for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • for children under 2 years of age consult a physician
Do Not Use
  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water
Active Ingredients

Lidocaine HCl 2.0%

Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away

Principal Display Panel – 2 Oz. Bottle

Burn

Spray

External Analgesic

  • Relieves Pain Fast
  • Washes Off Easily

#610 2 Fl. Oz. (59 mL)

Mfd. For

Afassco

MINDEN, NV 89423


Structured Label Content

Uses

Temporary pain relief for minor burns

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and returns

Purpose

Topical pain relief

Warnings

For external use only

Directions
  • for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • for children under 2 years of age consult a physician
Do Not Use (Do not use)
  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water
Active Ingredients

Lidocaine HCl 2.0%

Inactive Ingredients (Inactive ingredients)

aloe vera, germaben II, propylene glycol, purified water

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

If swallowed get medical help or contact a Poison Control Center right away

Principal Display Panel – 2 Oz. Bottle (PRINCIPAL DISPLAY PANEL – 2 oz. bottle)

Burn

Spray

External Analgesic

  • Relieves Pain Fast
  • Washes Off Easily

#610 2 Fl. Oz. (59 mL)

Mfd. For

Afassco

MINDEN, NV 89423


Advanced Ingredient Data


Raw Label Data

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