3dfb4c70-1bbf-4c77-9d8d-e135dbea15d2

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

Purpose

Topical pain relief

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

Temporary pain relief for minor burns

Purpose

Topical pain relief

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
Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Description

Drug Facts

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

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%

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

Warnings

For external use only

Uses

Temporary pain relief for minor burns

Purpose

Topical pain relief

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
Inactive Ingredients (Inactive ingredients)

aloe vera, germaben II, propylene glycol, purified water

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

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%

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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