SPL v2
SPL
SPL Set ID eaf73161-8597-4575-8b0f-be3e3389e5cc
Route
TOPICAL
Published
Effective Date 2014-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Diazolidinyl Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-08-13

Description

Drug Facts

Purpose

Topical Pain Relief


Medication Information

Purpose

Topical Pain Relief

Description

Drug Facts

Uses

temporary pain relief associated with minor 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 50566-9

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

Section 51945-4

Burn Spray

Pain relieving spray for use on minor burns.

M5082

3 fl. oz. (88.7 ml.)

----------

FIRST AID ONLY

Distributed by First Aid Only, Inc.

Vancouver, WA 96882 USA

Warnings

For external use only.

Directions
  • Adults and children 2 years of age and older; spray an even layer of burn spray over 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 area
  • 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


Structured Label Content

Uses

temporary pain relief associated with minor 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 50566-9 (50566-9)

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

Section 51945-4 (51945-4)

Burn Spray

Pain relieving spray for use on minor burns.

M5082

3 fl. oz. (88.7 ml.)

----------

FIRST AID ONLY

Distributed by First Aid Only, Inc.

Vancouver, WA 96882 USA

Purpose

Topical Pain Relief

Warnings

For external use only.

Directions
  • Adults and children 2 years of age and older; spray an even layer of burn spray over 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 area
  • 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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)