medi-first burn spray

medi-first burn spray
SPL v5
SPL
SPL Set ID b3ebf104-cc51-0ef5-e053-2a95a90a25c9
Route
topical
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
trolamine peg-40 castor oil octoxynol 9 phenoxyethanol water propylene glycol hypromelloses glycerin tea tree oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-03-01

Description

Active ingredient Lidocaine HCl 2.0%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Active Ingredient

Active ingredient

Lidocaine HCl 2.0%

Indications and Usage

Uses

Temporary pain relief associated with minor burns

Dosage and Administration

Directions

  • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on children under 12 years of age
Description

Active ingredient Lidocaine HCl 2.0%

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 50570-1

Do not use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Section 51727-6

Inactive ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydronated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Section 53413-1

Questions or comments? 1-800-634-7680

Section 55105-1

Purpose

Topical pain relief

Medi First Burn Spray Label

Medi-First°

Burn Spray

Pump Spray

Lidocaine HCl 2.0%

Topical Analgesic

Relieves pain in minor burns

Store at 68°-77°F (20°-25°C)

2 FL OZ (59.1 ML)


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active ingredient

Lidocaine HCl 2.0%

Indications and Usage (34067-9)

Uses

Temporary pain relief associated with minor burns

Dosage and Administration (34068-7)

Directions

  • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on children under 12 years of age
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 50570-1 (50570-1)

Do not use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Section 51727-6 (51727-6)

Inactive ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydronated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 55105-1 (55105-1)

Purpose

Topical pain relief

Medi First Burn Spray Label (Medi-First Burn Spray Label)

Medi-First°

Burn Spray

Pump Spray

Lidocaine HCl 2.0%

Topical Analgesic

Relieves pain in minor burns

Store at 68°-77°F (20°-25°C)

2 FL OZ (59.1 ML)


Advanced Ingredient Data


Raw Label Data

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