72976-004 First Shield

72976-004 First Shield
SPL v2
SPL
SPL Set ID e022bf8f-3dd8-de22-e053-2995a90a219b
Route
TOPICAL
Published
Effective Date 2022-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Phenoxyethanol Water Glycerin Tea Tree Oil Hypromelloses Propylene Glycol Trolamine Octoxynol 9 Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-30

Description

Active ingredient Lidocaine HCI 2.0%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

Temporary pain relief associated with minor burns

Dosage and Administration

Directions

  • spray an over 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 HCI 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 a 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 methylcllulose, melaleuce alterniflia (tea tree) leaf oil, octoxynol 9,PEEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Section 51945-4

Section 53413-1

Questions or comments? 800-325-4655

Section 55105-1

Purpose

Topical pain relief

Section 55106-9

Active ingredient

Lidocaine HCI 2.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary pain relief associated with minor burns

Dosage and Administration (34068-7)

Directions

  • spray an over 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
Warnings and Precautions (34071-1)

Warnings

For external use only.

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 a 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 methylcllulose, melaleuce alterniflia (tea tree) leaf oil, octoxynol 9,PEEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 800-325-4655

Section 55105-1 (55105-1)

Purpose

Topical pain relief

Section 55106-9 (55106-9)

Active ingredient

Lidocaine HCI 2.0%


Advanced Ingredient Data


Raw Label Data

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