Burn Relief Spray

Burn Relief Spray
SPL v9
SPL
SPL Set ID b25dc0df-02d0-41ac-b36c-2c04baa77ef2
Route
TOPICAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.64 g)
Inactive Ingredients
Butane Carbomer Copolymer Type A Diazolidinyl Urea Aloe Vera Leaf Disodium Cocoamphodipropionate Edetate Disodium Glycerin Methylparaben Propane Propylene Glycol .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-19

Description

Lidocaine 0.5%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Lidocaine 0.5%

Uses

for temporary relief of pain and itching associated with:

  • sunburn
  • minor burns
  • minor cuts
  • insect bites
  • scrapes
  • minor skin irritations
Warnings

For external use only.

Directions
  • shake can well
  • for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • for children under 2 years of age: consult a doctor
  • to apply to face spray in palm of hand and gently apply
Do Not Use

in large quantities, particularly over raw surfaces or blistered areas.

Flammable:

Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling the contents can be harmul or fatal.

Questions?

Call 1-866-964-0939

Other Information

store between 20º to 25ºC (68º to 77ºF)

Active Ingredients

Lidocaine 0.5%

Inactive Ingredients

aloe barbadensis leaf juice, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, water

Principal Display Panel

CareOne

Burn Relief Spray

Lidocaine

Relieves Pain and Itching from Sunburn, Minor Burns and Insect Bites

Cools, Moisturizes and Soothes Sunburned Skin

NET WT 4.5 OZ (127g)

When Using This Product
  • do not get into eyes
  • ask a doctor before using on children under 2 years of age
Stop Use and Ask A Doctor If
  • condition gets worse
  • symptoms last more than 7 days or clear up and occur again in a few days
Keep Out of Reach of Children.

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


Structured Label Content

Uses

for temporary relief of pain and itching associated with:

  • sunburn
  • minor burns
  • minor cuts
  • insect bites
  • scrapes
  • minor skin irritations
Purpose

External analgesic

Warnings

For external use only.

Directions
  • shake can well
  • for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • for children under 2 years of age: consult a doctor
  • to apply to face spray in palm of hand and gently apply
Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas.

Flammable:

Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling the contents can be harmul or fatal.

Questions?

Call 1-866-964-0939

Other Information (Other information)

store between 20º to 25ºC (68º to 77ºF)

Active Ingredients

Lidocaine 0.5%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, water

Principal Display Panel

CareOne

Burn Relief Spray

Lidocaine

Relieves Pain and Itching from Sunburn, Minor Burns and Insect Bites

Cools, Moisturizes and Soothes Sunburned Skin

NET WT 4.5 OZ (127g)

When Using This Product (When using this product)
  • do not get into eyes
  • ask a doctor before using on children under 2 years of age
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition gets worse
  • symptoms last more than 7 days or clear up and occur again in a few days
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.


Advanced Ingredient Data


Raw Label Data

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